Trial Outcomes & Findings for Feasibility Trial of a Stakeholder-enhanced Lay-navigator-delivered Intervention (ImPart-Multi) (NCT NCT06067009)
NCT ID: NCT06067009
Last Updated: 2026-02-13
Results Overview
Through qualitative interviews, participants reported if ImPart-Mulit participation and trial procedures were acceptable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Completed at 12 week survey data collection
Results posted on
2026-02-13
Participant Flow
As a condition of enrollment, patients and caregivers completed baseline surveys. The number of participants indicates individual participant numbers, not the total number of dyads.
Participant milestones
| Measure |
Group 1 - Communication
Patient participants in this group completed one session of communication training and will have 1 follow up call a month after the session has been completed. Caregiver and patient participants completed data collection at study start and 12 weeks after enrollment.
|
Group 2 - Social Support Effectiveness
Patient participants in this group completed 3 sessions of social support effectiveness training. All will complete 1 follow-up call after the 3 sessions have been completed. Patient and caregiver participants compelted data collection at study start and at 12 weeks of enrollment.
|
Group 3 - Communication and Social Support Effectiveness
Patient participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks.
|
Group 4 - Wait-listed Control
Patient participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Patients and caregivers in this group compelted data collection at baseline and 12 weeks. . After 12 week data collection, patients will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. There was no addtional data collection after compeletion of sessions.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
4
|
|
Overall Study
Baseline Data Completion -Patients
|
3
|
3
|
3
|
2
|
|
Overall Study
Baseline Data Completion - Caregivers
|
3
|
3
|
3
|
2
|
|
Overall Study
12 week data collection - Patient
|
3
|
2
|
2
|
2
|
|
Overall Study
12 week data collection - Caregivers
|
3
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
6
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
Group 1 - Communication
Patient participants in this group completed one session of communication training and will have 1 follow up call a month after the session has been completed. Caregiver and patient participants completed data collection at study start and 12 weeks after enrollment.
|
Group 2 - Social Support Effectiveness
Patient participants in this group completed 3 sessions of social support effectiveness training. All will complete 1 follow-up call after the 3 sessions have been completed. Patient and caregiver participants compelted data collection at study start and at 12 weeks of enrollment.
|
Group 3 - Communication and Social Support Effectiveness
Patient participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks.
|
Group 4 - Wait-listed Control
Patient participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Patients and caregivers in this group compelted data collection at baseline and 12 weeks. . After 12 week data collection, patients will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. There was no addtional data collection after compeletion of sessions.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
0
|
Baseline Characteristics
patients and caregivers are split apart and represented in separate rows
Baseline characteristics by cohort
| Measure |
Group 1 - Communication
n=6 Participants
Patient Participants in this group will complete one session of communication training and will have 1 follow up call a month after the session has been completed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks.
|
Group 2 - Social Support Effectiveness
n=6 Participants
Patient Participants in this group will complete 3 sessions of social support effectiveness training. All will complete 1 follow-up call after the 3 sessions have been completed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks.
|
Group 3 - Communication and Social Support Effectiveness
n=6 Participants
Patient Participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks.
|
Group 4 - Wait-listed Control
n=4 Participants
Patient Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Patients and caregivers in this group compelted data collection at baseline and 12 weeks. After 12 week data collection, they will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. No additional data collection occured after recieving sessions for this group, our goal was equity.
|
Total
n=22 Participants
Total of all reporting groups
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|---|---|---|---|---|---|
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Age, Categorical
patients · <=18 years
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Age, Categorical
patients · Between 18 and 65 years
|
2 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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2 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Age, Categorical
patients · >=65 years
|
1 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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3 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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3 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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2 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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9 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Age, Categorical
caregivers · <=18 years
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Age, Categorical
caregivers · Between 18 and 65 years
|
2 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
2 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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2 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
1 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
|
7 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Age, Categorical
caregivers · >=65 years
|
1 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
1 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
1 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
1 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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4 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Sex: Female, Male
Patients · Female
|
2 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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2 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
1 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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2 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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7 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Sex: Female, Male
Patients · Male
|
1 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
1 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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2 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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4 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Sex: Female, Male
Caregivers · Female
|
3 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
1 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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2 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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2 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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8 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Sex: Female, Male
Caregivers · Male
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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2 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
1 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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3 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
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|
Race (NIH/OMB)
patients · American Indian or Alaska Native
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Race (NIH/OMB)
patients · Asian
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Race (NIH/OMB)
patients · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
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|
Race (NIH/OMB)
patients · Black or African American
|
3 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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3 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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2 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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2 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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10 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Race (NIH/OMB)
patients · White
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
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|
Race (NIH/OMB)
patients · More than one race
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Race (NIH/OMB)
patients · Unknown or Not Reported
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
1 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
|
1 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Race (NIH/OMB)
caregivers · American Indian or Alaska Native
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Race (NIH/OMB)
caregivers · Asian
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Race (NIH/OMB)
caregivers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Race (NIH/OMB)
caregivers · Black or African American
|
3 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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3 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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3 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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1 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
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10 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Race (NIH/OMB)
caregivers · White
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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1 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
|
1 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Race (NIH/OMB)
caregivers · More than one race
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Race (NIH/OMB)
caregivers · Unknown or Not Reported
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
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0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Ethnicity (NIH/OMB)
Patients · Hispanic or Latino
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Ethnicity (NIH/OMB)
Patients · Not Hispanic or Latino
|
3 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
3 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
2 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
2 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
|
10 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Ethnicity (NIH/OMB)
Patients · Unknown or Not Reported
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
1 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
|
1 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Ethnicity (NIH/OMB)
caregivers · Hispanic or Latino
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Ethnicity (NIH/OMB)
caregivers · Not Hispanic or Latino
|
3 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
3 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
3 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
2 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
|
11 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Ethnicity (NIH/OMB)
caregivers · Unknown or Not Reported
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=3 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=2 Participants • patients and caregivers are split apart and represented in separate rows
|
0 Participants
n=11 Participants • patients and caregivers are split apart and represented in separate rows
|
|
Region of Enrollment
United States
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
22 Participants
n=22 Participants
|
PRIMARY outcome
Timeframe: Completed at 12 week survey data collectionPopulation: Patient and caregiver participants could completed an investigator developed semi-structured interview. All did not choose to participate. For ImPart-Multi acceptable theme only patient data is represented as they are the only individuals who participated in sessions. Patients and caregivers were recruited, recieved surveys, and could give feedback on study procedures realted to implementation. Under the theme of Study Proedures Acceptable both are represented.
Through qualitative interviews, participants reported if ImPart-Mulit participation and trial procedures were acceptable.
Outcome measures
| Measure |
Group 4 - Wait-listed Control
n=4 Participants
Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Data collection on patients and caregivers occurred at 12 weeks. After 12 week data collection, they will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. This measure was not collected post-crossover again.
|
Group 1 - Communication
n=6 Participants
Patient Participants in this group will complete one session of communication training and will have 1 follow up call a month after the session has been completed. Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
Group 2 - Social Support Effectiveness
n=6 Participants
Patient participants in this group will complete 3 sessions of social support effectiveness training. All will complete 1 follow-up call after the 3 sessions have been completed Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
Group 3 - Communication and Social Support Effectiveness
n=6 Participants
Patient Participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
|---|---|---|---|---|
|
Acceptability Interviews (Investigator Developed)
Theme ImPart-Multi Acceptable
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Acceptability Interviews (Investigator Developed)
Study Procedures Acceptable
|
3 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: OInly patients completed the intervention sessions thus they are the only individuals who compelted the FIM.
The FIM is a 4 question survey asking questions regarding how feasible it was to complete the ImPart-Multi Intervention on a 5 point likert scale (1-5). The closer the mean to 5 the greater preceived feasibiltiy. Only patients completed sessions, so only patient data is represented in this measures outcomes. The closer to 5 the mean, the more feasiable the intervention was precieved. All patients did not complete this measure.
Outcome measures
| Measure |
Group 4 - Wait-listed Control
n=1 Participants
Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Data collection on patients and caregivers occurred at 12 weeks. After 12 week data collection, they will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. This measure was not collected post-crossover again.
|
Group 1 - Communication
n=3 Participants
Patient Participants in this group will complete one session of communication training and will have 1 follow up call a month after the session has been completed. Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
Group 2 - Social Support Effectiveness
n=1 Participants
Patient participants in this group will complete 3 sessions of social support effectiveness training. All will complete 1 follow-up call after the 3 sessions have been completed Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
Group 3 - Communication and Social Support Effectiveness
n=1 Participants
Patient Participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
|---|---|---|---|---|
|
Feasibility of Intervention Measure
|
3 unites on a scale
Standard Deviation 0
|
1.67 unites on a scale
Standard Deviation 1.15
|
3 unites on a scale
Standard Deviation 0
|
4 unites on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: From enrollment to end of study at 12 weeksPopulation: Only patient participants completed the Decision Conflict Scale, some patients did not complte all measures at baseline or at 12 week data collection
The decision conflict scale is a 16-item total scale, using a 0-4 Likert scale to assess decision conflict. The total sum score was used as an indicator of overall decision conflict. The higher the number (mean), the greater the decision conflict. Total instrument scores range from 0-100.
Outcome measures
| Measure |
Group 4 - Wait-listed Control
n=2 Participants
Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Data collection on patients and caregivers occurred at 12 weeks. After 12 week data collection, they will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. This measure was not collected post-crossover again.
|
Group 1 - Communication
n=3 Participants
Patient Participants in this group will complete one session of communication training and will have 1 follow up call a month after the session has been completed. Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
Group 2 - Social Support Effectiveness
n=3 Participants
Patient participants in this group will complete 3 sessions of social support effectiveness training. All will complete 1 follow-up call after the 3 sessions have been completed Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
Group 3 - Communication and Social Support Effectiveness
n=2 Participants
Patient Participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
|---|---|---|---|---|
|
Decision Conflict Scale (DCS)
Decision Conflict Scale Baseline
|
24.22 units on a scale
Standard Deviation 14.37
|
22.40 units on a scale
Standard Deviation 28.13
|
28.13 units on a scale
Standard Deviation 17.75
|
30.47 units on a scale
Standard Deviation 9.94
|
|
Decision Conflict Scale (DCS)
Decision Conflict Scale 12 week
|
11.05 units on a scale
Standard Deviation 19.92
|
16.15 units on a scale
Standard Deviation 14.18
|
25.01 units on a scale
Standard Deviation 13.26
|
13.23 units on a scale
Standard Deviation 26.56
|
SECONDARY outcome
Timeframe: From enrollment to end of study at 12 weeksPopulation: Patient participants were the only ones who completed this measure
The Social Support Effectiveness Questionnaire is a 25-item measuring perceptions of help received in the last 3 months for patients only, on a likert scale 0-4. Total scores range from 0-80, Likert scale 0-4, with higher scores indicating greater social support.
Outcome measures
| Measure |
Group 4 - Wait-listed Control
n=2 Participants
Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Data collection on patients and caregivers occurred at 12 weeks. After 12 week data collection, they will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. This measure was not collected post-crossover again.
|
Group 1 - Communication
n=3 Participants
Patient Participants in this group will complete one session of communication training and will have 1 follow up call a month after the session has been completed. Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
Group 2 - Social Support Effectiveness
n=3 Participants
Patient participants in this group will complete 3 sessions of social support effectiveness training. All will complete 1 follow-up call after the 3 sessions have been completed Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
Group 3 - Communication and Social Support Effectiveness
n=3 Participants
Patient Participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
|---|---|---|---|---|
|
Social Support Effectiveness-Questionnaire
SSES baseline
|
61.18 units on a scale
Standard Deviation 11.80
|
68.00 units on a scale
Standard Deviation 11.53
|
59.97 units on a scale
Standard Deviation 8.74
|
62.00 units on a scale
Standard Deviation 6.25
|
|
Social Support Effectiveness-Questionnaire
SSES 12 weeks
|
57.50 units on a scale
Standard Deviation 7.78
|
76.00 units on a scale
Standard Deviation 3.61
|
46.5 units on a scale
Standard Deviation 21.92
|
50.00 units on a scale
Standard Deviation 8.49
|
SECONDARY outcome
Timeframe: From enrollment to end of study at 12 weeksPopulation: This measure was only collected on patient participants, all did not compete 12 week data collection. Also this is a subscaled instrument where if the answer is not appilicable directions indicate questions can be skipped.
The KDQOL-36 is a 36-item instrument measuring 3 domains: Symptoms and problems of kidney disease, effect of kidney disease, and burden of kidney disease, using a Likert scale 1-5. All domains' total scores can range from 0 to 100. For the symptoms and problems of kidney disease scale, greater numbers indicates greater quality of life. For the effects of kidney disease, the greater the number (mean), the more the patient feels the disease and its treatment have less negative impact on their life, indicating a better quality of life in that specific area. For the burden of kideny disease subscale higher scores means a better, less burdensome quality of life
Outcome measures
| Measure |
Group 4 - Wait-listed Control
n=2 Participants
Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Data collection on patients and caregivers occurred at 12 weeks. After 12 week data collection, they will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. This measure was not collected post-crossover again.
|
Group 1 - Communication
n=3 Participants
Patient Participants in this group will complete one session of communication training and will have 1 follow up call a month after the session has been completed. Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
Group 2 - Social Support Effectiveness
n=3 Participants
Patient participants in this group will complete 3 sessions of social support effectiveness training. All will complete 1 follow-up call after the 3 sessions have been completed Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
Group 3 - Communication and Social Support Effectiveness
n=3 Participants
Patient Participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
|---|---|---|---|---|
|
Kidney Disease Quality of Life Scale (KDQOL-36)
KDQOL Symptom/problem list baseline
|
75.00 units on a scale
Standard Deviation 6.43
|
95.45 units on a scale
Standard Deviation 7.88
|
62.88 units on a scale
Standard Deviation 22.07
|
78.85 units on a scale
Standard Deviation 8.54
|
|
Kidney Disease Quality of Life Scale (KDQOL-36)
KDQOL Symptom/problem list 12 week
|
72.73 units on a scale
Standard Deviation 22.50
|
100 units on a scale
Standard Deviation 0.00
|
71.59 units on a scale
Standard Deviation 8.03
|
75.00 units on a scale
Standard Deviation 16.01
|
|
Kidney Disease Quality of Life Scale (KDQOL-36)
KD QOL Effects of kidney disease baseline
|
87.50 units on a scale
Standard Deviation .0
|
93.75 units on a scale
Standard Deviation 10.83
|
66.67 units on a scale
Standard Deviation 17.21
|
89.58 units on a scale
Standard Deviation 7.22
|
|
Kidney Disease Quality of Life Scale (KDQOL-36)
KD QOL Effects of kidney disease 12 weeks
|
81.25 units on a scale
Standard Deviation .0
|
95.84 units on a scale
Standard Deviation 10.83
|
84.38 units on a scale
Standard Deviation 4.42
|
82.82 units on a scale
Standard Deviation 2.21
|
|
Kidney Disease Quality of Life Scale (KDQOL-36)
KD QOL Burden of kidney disease baseline
|
87.50 units on a scale
Standard Deviation 0.00
|
93.75 units on a scale
Standard Deviation 10.83
|
70.83 units on a scale
Standard Deviation 31.48
|
81.25 units on a scale
Standard Deviation 16.54
|
|
Kidney Disease Quality of Life Scale (KDQOL-36)
KD QOL Burden of kidney disease 12 week
|
75.00 units on a scale
Standard Deviation 26.52
|
100.00 units on a scale
Standard Deviation .00
|
81.25 units on a scale
Standard Deviation .00
|
84.38 units on a scale
Standard Deviation 4.42
|
SECONDARY outcome
Timeframe: From enrollment to end of study at 12 weeksPopulation: Caregiver participants are the only individuals who completed this measure.
The PROMIS Global Health is a 10 items measure of global health-related quality of life in 2 domains, physical and mental health. social domains. It yields two summary scores: Global Physical Health (GPH): Reflects physical health, fatigue, pain, and ability to perform physical activities. Global Mental Health (GMH): Reflects mental health, emotional distress, and satisfaction with social activities and roles. Each item uses a 5-point Likert scale (e.g., Excellent to Poor, Never to Always). Pain is rated on a 0-10 numeric scale and recoded to a 5-point scale for scoring. Raw scores for GPH and GMH are calculated by summing four designated items for each domain. Raw scores are converted to T-scores using PROMIS scoring tables or the HealthMeasures Scoring Service. T-scores are standardized to the U.S. general population (Mean = 50, SD = 10). Higher T-scores indicate better health status.
Outcome measures
| Measure |
Group 4 - Wait-listed Control
n=2 Participants
Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Data collection on patients and caregivers occurred at 12 weeks. After 12 week data collection, they will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. This measure was not collected post-crossover again.
|
Group 1 - Communication
n=3 Participants
Patient Participants in this group will complete one session of communication training and will have 1 follow up call a month after the session has been completed. Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
Group 2 - Social Support Effectiveness
n=3 Participants
Patient participants in this group will complete 3 sessions of social support effectiveness training. All will complete 1 follow-up call after the 3 sessions have been completed Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
Group 3 - Communication and Social Support Effectiveness
n=3 Participants
Patient Participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
|---|---|---|---|---|
|
PROMIS Global Health 10
PROMIS 10 baseline Physical Health t-Score
|
46.56 T-scores (converted)
Standard Deviation 6.01
|
34.87 T-scores (converted)
Standard Deviation 13.21
|
38.20 T-scores (converted)
Standard Deviation 1.39
|
31.57 T-scores (converted)
Standard Deviation 10.10
|
|
PROMIS Global Health 10
PROMIS 10 12 week Physical Health t-Score
|
45.00 T-scores (converted)
Standard Deviation 3.82
|
38.20 T-scores (converted)
Standard Deviation 1.39
|
36.10 T-scores (converted)
Standard Deviation 5.23
|
33.65 T-scores (converted)
Standard Deviation 1.77
|
|
PROMIS Global Health 10
PROMIS 10 baseline Mental Health t-Score
|
49.55 T-scores (converted)
Standard Deviation 5.30
|
38.17 T-scores (converted)
Standard Deviation 11.87
|
40.0 T-scores (converted)
Standard Deviation 4.92
|
32.57 T-scores (converted)
Standard Deviation 6.47
|
|
PROMIS Global Health 10
PROMIS 10 12 week Mental Health t-Score
|
50.90 T-scores (converted)
Standard Deviation 7.21
|
37.87 T-scores (converted)
Standard Deviation 6.15
|
41.15 T-scores (converted)
Standard Deviation 3.32
|
28.20 T-scores (converted)
Standard Deviation 4.38
|
SECONDARY outcome
Timeframe: From enrollment to end of study at 12 weeksPopulation: Not all participants completed 12 week data collection on this instrument
The Dyadic Coping Inventory is a 37 item instrument designed to measure perceived communication and dyadic coping. The total score ranges from 35-175, items are scored 1-5 (rarely to ofetn). Higher scores indicated better dyadic coping: below 111 (low); 111-145 (normal); and above 145 (high).
Outcome measures
| Measure |
Group 4 - Wait-listed Control
n=4 Participants
Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Data collection on patients and caregivers occurred at 12 weeks. After 12 week data collection, they will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. This measure was not collected post-crossover again.
|
Group 1 - Communication
n=6 Participants
Patient Participants in this group will complete one session of communication training and will have 1 follow up call a month after the session has been completed. Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
Group 2 - Social Support Effectiveness
n=6 Participants
Patient participants in this group will complete 3 sessions of social support effectiveness training. All will complete 1 follow-up call after the 3 sessions have been completed Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
Group 3 - Communication and Social Support Effectiveness
n=6 Participants
Patient Participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers.
|
|---|---|---|---|---|
|
Dyadic Coping Inventory
Dyadic Coping Inventory 12 weeks
|
97.67 units on a scale
Standard Deviation 28.89
|
138.67 units on a scale
Standard Deviation 10.80
|
112.75 units on a scale
Standard Deviation 11.21
|
134.25 units on a scale
Standard Deviation 2.06
|
|
Dyadic Coping Inventory
Dyadic Coping Inventory baseline
|
83.25 units on a scale
Standard Deviation 33.32
|
137.1667 units on a scale
Standard Deviation 5.31
|
133.00 units on a scale
Standard Deviation 11.71
|
116.50 units on a scale
Standard Deviation 16.26
|
Adverse Events
Group 1 - Communication
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 - Social Support Effectiveness
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3 - Communication and Social Support Effectiveness
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4 - Wait-listed Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place