Trial Outcomes & Findings for Pilot Testing Dementia-Enhanced Training and Tool for Home Hospice Clinicians (NCT NCT05719077)

NCT ID: NCT05719077

Last Updated: 2026-07-16

Results Overview

The investigators will assess this outcome using the validated, 12-item Zarit Caregiver Burden Inventory. Summed scores range from 0-48, with higher scores indicating greater burden. The investigators will assess changes in reported caregiver burden between baseline and the first subsequent hospice visit and compare differences in changes between the intervention and control groups. Because family caregiver participants are relatives of hospice patients that may die (at which point they will no longer be receiving home visits from nurses and social workers), the investigators expect that many participants will not complete all four time points of data collection.

Recruitment status

COMPLETED

Study phase

Target enrollment

93 participants

Primary outcome timeframe

Baseline and through first subsequent hospice visit, an average of 8 weeks

Results posted on

2026-07-16

Participant Flow

No enrolled participants were excluded from the study before assignment to a study group.

Participant milestones

Participant milestones
Measure	Intervention Clinicians IDTs were randomly assigned to intervention or control; clinician participants were assigned according to the randomization of their IDT. Intervention clinicians completed baseline measures, completed educational modules and corresponding measures, used the intervention tool up to four times with each enrolled FCP on their caseload, and completed a post-intervention measure.	Control Clinicians IDTs were randomly assigned to intervention or control; clinician participants were assigned according to the randomization of their IDT. Control clinicians completed baseline measures and listened to a 10-minute presentation on outcomes for Patients living with dementia in hospice. FCP on their caseloads received standard hospice care.	Intervention Family Care Partners (FCP) FCPs were assigned to intervention or control based on the assignment of their clinician enrolled in the study. Intervention FCPs completed baseline measures and study measures up to four times after each clinician visit, including additional measures corresponding to the use of the tool which clinicians were instructed to use with them at each appropriate visit. They also completed a post-intervention measure.	Control Family Care Partners FCPs were assigned to intervention or control based on the assignment of their clinician enrolled in the study. Control FCP received standard hospice care and completed baseline measures and study measures up to four times after each clinician visit.
Overall Study STARTED	15	14	37	27
Overall Study COMPLETED	13	14	33	21
Overall Study NOT COMPLETED	2	0	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Clinicians IDTs were randomly assigned to intervention or control; clinician participants were assigned according to the randomization of their IDT. Intervention clinicians completed baseline measures, completed educational modules and corresponding measures, used the intervention tool up to four times with each enrolled FCP on their caseload, and completed a post-intervention measure.	Intervention Family Care Partners (FCP) FCPs were assigned to intervention or control based on the assignment of their clinician enrolled in the study. Intervention FCPs completed baseline measures and study measures up to four times after each clinician visit, including additional measures corresponding to the use of the tool which clinicians were instructed to use with them at each appropriate visit. They also completed a post-intervention measure.	Control Family Care Partners FCPs were assigned to intervention or control based on the assignment of their clinician enrolled in the study. Control FCP received standard hospice care and completed baseline measures and study measures up to four times after each clinician visit.
Overall Study Lost to Follow-up	2	0	0
Overall Study Withdrawal by Subject	0	1	1
Overall Study Became ineligible	0	2	5
Overall Study Scheduled study conclusion	0	1	0

Baseline Characteristics

Age was self-reported. These data were not self-reported for: 1 intervention clinician, 1 control clinician, 2 intervention FCP and 3 control FCP.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Clinicians n=14 Participants IDTs were randomly assigned to intervention or control; clinician participants were assigned according to the randomization of their IDT. Intervention clinicians completed baseline measures, completed educational modules and corresponding measures, used the intervention tool up to four times with each enrolled FCP on their caseload, and completed a post-intervention measure.	Control Clinicians n=14 Participants IDTs were randomly assigned to intervention or control; clinician participants were assigned according to the randomization of their IDT. Control clinicians completed baseline measures and listened to a 10-minute presentation on outcomes for Patients living with dementia in hospice. FCP on their caseloads received standard hospice care.	Intervention Family Care Partners (FCP) n=35 Participants FCPs were assigned to intervention or control based on the assignment of their clinician enrolled in the study. Intervention FCPs completed baseline measures and study measures up to four times after each clinician visit, including additional measures corresponding to the use of the tool which clinicians were instructed to use with them at each appropriate visit. They also completed a post-intervention measure.	Control Family Care Partners n=26 Participants FCPs were assigned to intervention or control based on the assignment of their clinician enrolled in the study. Control FCP received standard hospice care and completed baseline measures and study measures up to four times after each clinician visit.	Total n=89 Participants Total of all reporting groups
Age, Continuous	43.8 years STANDARD_DEVIATION 11.4 • n=13 Participants • Age was self-reported. These data were not self-reported for: 1 intervention clinician, 1 control clinician, 2 intervention FCP and 3 control FCP.	49.4 years STANDARD_DEVIATION 11.3 • n=13 Participants • Age was self-reported. These data were not self-reported for: 1 intervention clinician, 1 control clinician, 2 intervention FCP and 3 control FCP.	58.2 years STANDARD_DEVIATION 13.5 • n=33 Participants • Age was self-reported. These data were not self-reported for: 1 intervention clinician, 1 control clinician, 2 intervention FCP and 3 control FCP.	62.7 years STANDARD_DEVIATION 11.0 • n=23 Participants • Age was self-reported. These data were not self-reported for: 1 intervention clinician, 1 control clinician, 2 intervention FCP and 3 control FCP.	55.8 years STANDARD_DEVIATION 13.7 • n=82 Participants • Age was self-reported. These data were not self-reported for: 1 intervention clinician, 1 control clinician, 2 intervention FCP and 3 control FCP.
Sex: Female, Male Female	10 Participants n=14 Participants • Sex was self reported. One control FCP did not report their sex.	13 Participants n=14 Participants • Sex was self reported. One control FCP did not report their sex.	31 Participants n=35 Participants • Sex was self reported. One control FCP did not report their sex.	19 Participants n=25 Participants • Sex was self reported. One control FCP did not report their sex.	73 Participants n=88 Participants • Sex was self reported. One control FCP did not report their sex.
Sex: Female, Male Male	4 Participants n=14 Participants • Sex was self reported. One control FCP did not report their sex.	1 Participants n=14 Participants • Sex was self reported. One control FCP did not report their sex.	4 Participants n=35 Participants • Sex was self reported. One control FCP did not report their sex.	6 Participants n=25 Participants • Sex was self reported. One control FCP did not report their sex.	15 Participants n=88 Participants • Sex was self reported. One control FCP did not report their sex.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=14 Participants	1 Participants n=14 Participants	3 Participants n=35 Participants	6 Participants n=26 Participants	10 Participants n=89 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=14 Participants	12 Participants n=14 Participants	32 Participants n=35 Participants	17 Participants n=26 Participants	75 Participants n=89 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants	1 Participants n=14 Participants	0 Participants n=35 Participants	3 Participants n=26 Participants	4 Participants n=89 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=35 Participants	0 Participants n=26 Participants	0 Participants n=89 Participants
Race (NIH/OMB) Asian	0 Participants n=14 Participants	2 Participants n=14 Participants	0 Participants n=35 Participants	0 Participants n=26 Participants	2 Participants n=89 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=35 Participants	0 Participants n=26 Participants	0 Participants n=89 Participants
Race (NIH/OMB) Black or African American	6 Participants n=14 Participants	5 Participants n=14 Participants	13 Participants n=35 Participants	7 Participants n=26 Participants	31 Participants n=89 Participants
Race (NIH/OMB) White	7 Participants n=14 Participants	6 Participants n=14 Participants	19 Participants n=35 Participants	15 Participants n=26 Participants	47 Participants n=89 Participants
Race (NIH/OMB) More than one race	1 Participants n=14 Participants	0 Participants n=14 Participants	1 Participants n=35 Participants	0 Participants n=26 Participants	2 Participants n=89 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants	1 Participants n=14 Participants	2 Participants n=35 Participants	4 Participants n=26 Participants	7 Participants n=89 Participants
Region of Enrollment United States	14 participants n=14 Participants	14 participants n=14 Participants	35 participants n=35 Participants	26 participants n=26 Participants	89 participants n=89 Participants
Zarit Burden Interview	—	—	16.6 units on a scale STANDARD_DEVIATION 7.2 • n=31 Participants • Measure collected for Family Care Participants (FCP) only. As such, no data collected from clinician participants. Collected at baseline and after each study-eligible visit (up to four). Of 35 intervention FCP providing some baseline data, 31 completed this measure. Of 26 control FCP providing some baseline data, 22 completed this measure. Baseline data was not collected from 4 intervention and 4 control FCP due to participant withdraw, FCP becoming ineligible, and scheduled study conclusion.	21.4 units on a scale STANDARD_DEVIATION 9.0 • n=22 Participants • Measure collected for Family Care Participants (FCP) only. As such, no data collected from clinician participants. Collected at baseline and after each study-eligible visit (up to four). Of 35 intervention FCP providing some baseline data, 31 completed this measure. Of 26 control FCP providing some baseline data, 22 completed this measure. Baseline data was not collected from 4 intervention and 4 control FCP due to participant withdraw, FCP becoming ineligible, and scheduled study conclusion.	18.6 units on a scale STANDARD_DEVIATION 8.3 • n=53 Participants • Measure collected for Family Care Participants (FCP) only. As such, no data collected from clinician participants. Collected at baseline and after each study-eligible visit (up to four). Of 35 intervention FCP providing some baseline data, 31 completed this measure. Of 26 control FCP providing some baseline data, 22 completed this measure. Baseline data was not collected from 4 intervention and 4 control FCP due to participant withdraw, FCP becoming ineligible, and scheduled study conclusion.
Dementia Knowledge and Attitudes Scale	34.4 units on a scale STANDARD_DEVIATION 5.5 • n=14 Participants • Measure was collected for clinician participants only. As such no information is reported for family care partner participants. Collected at baseline (pre-training) and after training for intervention or control presentation (post-training). 29 clinicians enrolled in the study and were randomized to intervention (n=15) or control (n=14) groups. However, 1 clinician in the intervention group was lost to follow-up prior to providing any baseline data.	37.1 units on a scale STANDARD_DEVIATION 5.7 • n=14 Participants • Measure was collected for clinician participants only. As such no information is reported for family care partner participants. Collected at baseline (pre-training) and after training for intervention or control presentation (post-training). 29 clinicians enrolled in the study and were randomized to intervention (n=15) or control (n=14) groups. However, 1 clinician in the intervention group was lost to follow-up prior to providing any baseline data.	—	—	35.8 units on a scale STANDARD_DEVIATION 5.7 • n=28 Participants • Measure was collected for clinician participants only. As such no information is reported for family care partner participants. Collected at baseline (pre-training) and after training for intervention or control presentation (post-training). 29 clinicians enrolled in the study and were randomized to intervention (n=15) or control (n=14) groups. However, 1 clinician in the intervention group was lost to follow-up prior to providing any baseline data.
Caregiving Self-Efficacy Scale	—	—	6.5 units on a scale STANDARD_DEVIATION 1.8 • n=31 Participants • Measure collected for Family Care Participants only. As such, no data collected from clinician participants. Collected at baseline and after each study-eligible visit (up to four times). Of 35 intervention FCP providing some baseline data, 31 completed this measure. Of 26 control FCP providing some baseline data, 22 completed this measure. Baseline data was not collected from 4 intervention and 4 control FCP due to participant withdraw, FCP becoming ineligible, and scheduled study conclusion.	5.7 units on a scale STANDARD_DEVIATION 2.1 • n=22 Participants • Measure collected for Family Care Participants only. As such, no data collected from clinician participants. Collected at baseline and after each study-eligible visit (up to four times). Of 35 intervention FCP providing some baseline data, 31 completed this measure. Of 26 control FCP providing some baseline data, 22 completed this measure. Baseline data was not collected from 4 intervention and 4 control FCP due to participant withdraw, FCP becoming ineligible, and scheduled study conclusion.	6.2 units on a scale STANDARD_DEVIATION 2.0 • n=53 Participants • Measure collected for Family Care Participants only. As such, no data collected from clinician participants. Collected at baseline and after each study-eligible visit (up to four times). Of 35 intervention FCP providing some baseline data, 31 completed this measure. Of 26 control FCP providing some baseline data, 22 completed this measure. Baseline data was not collected from 4 intervention and 4 control FCP due to participant withdraw, FCP becoming ineligible, and scheduled study conclusion.
Family Caregiver Preparedness Scale	—	—	2.8 units on a scale STANDARD_DEVIATION 0.6 • n=31 Participants • Measure collected for Family Care Participants only. As such, no data collected from clinician participants. Collected at baseline and after each study-eligible visit (up to four times). Of 35 intervention FCP providing some baseline data, 31 completed this measure. Of 26 control FCP providing some baseline data, 22 completed this measure. Baseline data was not collected from 4 intervention and 4 control FCP due to participant withdraw, FCP becoming ineligible, and scheduled study conclusion.	2.5 units on a scale STANDARD_DEVIATION 0.7 • n=22 Participants • Measure collected for Family Care Participants only. As such, no data collected from clinician participants. Collected at baseline and after each study-eligible visit (up to four times). Of 35 intervention FCP providing some baseline data, 31 completed this measure. Of 26 control FCP providing some baseline data, 22 completed this measure. Baseline data was not collected from 4 intervention and 4 control FCP due to participant withdraw, FCP becoming ineligible, and scheduled study conclusion.	2.7 units on a scale STANDARD_DEVIATION 0.6 • n=53 Participants • Measure collected for Family Care Participants only. As such, no data collected from clinician participants. Collected at baseline and after each study-eligible visit (up to four times). Of 35 intervention FCP providing some baseline data, 31 completed this measure. Of 26 control FCP providing some baseline data, 22 completed this measure. Baseline data was not collected from 4 intervention and 4 control FCP due to participant withdraw, FCP becoming ineligible, and scheduled study conclusion.

PRIMARY outcome

Timeframe: Baseline and through first subsequent hospice visit, an average of 8 weeks

Population: Assessed for FCP only. Includes FCP in intervention and control groups who provided data at baseline and following first subsequent hospice visit.

Outcome measures

Outcome measures
Measure	Intervention Clinicians IDTs were randomly assigned to intervention or control; clinician participants were assigned according to the randomization of their IDT. Intervention clinicians completed baseline measures, completed educational modules and corresponding measures, used the intervention tool up to four times with each enrolled FCP on their caseload, and completed a post-intervention measure.	Control Clinicians IDTs were randomly assigned to intervention or control; clinician participants were assigned according to the randomization of their IDT. Control clinicians completed baseline measures and listened to a 10-minute presentation on outcomes for Patients living with dementia in hospice. FCP on their caseloads received standard hospice care.	Intervention Family Care Partners (FCP) n=26 Participants FCPs were assigned to intervention or control based on the assignment of their clinician enrolled in the study. Intervention FCPs completed baseline measures and study measures up to four times after each clinician visit, including additional measures corresponding to the use of the tool which clinicians were instructed to use with them at each appropriate visit. They also completed a post-intervention measure.	Control Family Care Partners n=15 Participants FCPs were assigned to intervention or control based on the assignment of their clinician enrolled in the study. Control FCP received standard hospice care and completed baseline measures and study measures up to four times after each clinician visit.
Family Caregiver Burden	—	—	-1.0 change in score on a scale Standard Deviation 3.5	0.4 change in score on a scale Standard Deviation 4.6

SECONDARY outcome

Timeframe: Baseline and through training completion, an average of 4 weeks

Population: Assessed in clinicians only. No data for FCP collected. Assessed only for clinicians who provided baseline and follow-up data.

The investigators will assess clinician knowledge of dementia-related issues at end of life using the validated, revised Dementia Knowledge Assessment Scale. The DKAS is a 25-item questionnaire, summed range: 0=50, with higher scores indicating greater knowledge. The investigators will assess changes in reported knowledge between baseline and after completing the training. The investigators will compare differences in changes between clinicians receiving the training (intervention) and those receiving a presentation on patterns of hospice outcomes for persons living with dementia (control).

Outcome measures

Outcome measures
Measure	Intervention Clinicians n=13 Participants IDTs were randomly assigned to intervention or control; clinician participants were assigned according to the randomization of their IDT. Intervention clinicians completed baseline measures, completed educational modules and corresponding measures, used the intervention tool up to four times with each enrolled FCP on their caseload, and completed a post-intervention measure.	Control Clinicians n=14 Participants IDTs were randomly assigned to intervention or control; clinician participants were assigned according to the randomization of their IDT. Control clinicians completed baseline measures and listened to a 10-minute presentation on outcomes for Patients living with dementia in hospice. FCP on their caseloads received standard hospice care.	Intervention Family Care Partners (FCP) FCPs were assigned to intervention or control based on the assignment of their clinician enrolled in the study. Intervention FCPs completed baseline measures and study measures up to four times after each clinician visit, including additional measures corresponding to the use of the tool which clinicians were instructed to use with them at each appropriate visit. They also completed a post-intervention measure.	Control Family Care Partners FCPs were assigned to intervention or control based on the assignment of their clinician enrolled in the study. Control FCP received standard hospice care and completed baseline measures and study measures up to four times after each clinician visit.
Clinician Knowledge of Dementia-related Issues at End of Life	0.7 change in score on a scale Standard Deviation 5.1	-2.1 change in score on a scale Standard Deviation 6.0	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and through first subsequent hospice visit, an average of 8 weeks

Population: Only assessed in FCP. No data collected for clinicians. Only assessed for FCP who completed both baseline and follow-up assessments.

The investigators will assess caregiver self-efficacy using the validated, 8-item Caregiver Self-Efficacy Scale (CSES). Mean scores range from 0-10, with higher scores indicating greater self-efficacy. The investigators will assess changes in caregiver self-efficacy between baseline and the first subsequent hospice visit and compare differences in changes between the intervention and control groups. The same issues due to attrition described in 1. Family Caregiver burden above also apply here.

Outcome measures

Outcome measures
Measure	Intervention Clinicians IDTs were randomly assigned to intervention or control; clinician participants were assigned according to the randomization of their IDT. Intervention clinicians completed baseline measures, completed educational modules and corresponding measures, used the intervention tool up to four times with each enrolled FCP on their caseload, and completed a post-intervention measure.	Control Clinicians IDTs were randomly assigned to intervention or control; clinician participants were assigned according to the randomization of their IDT. Control clinicians completed baseline measures and listened to a 10-minute presentation on outcomes for Patients living with dementia in hospice. FCP on their caseloads received standard hospice care.	Intervention Family Care Partners (FCP) n=26 Participants FCPs were assigned to intervention or control based on the assignment of their clinician enrolled in the study. Intervention FCPs completed baseline measures and study measures up to four times after each clinician visit, including additional measures corresponding to the use of the tool which clinicians were instructed to use with them at each appropriate visit. They also completed a post-intervention measure.	Control Family Care Partners n=15 Participants FCPs were assigned to intervention or control based on the assignment of their clinician enrolled in the study. Control FCP received standard hospice care and completed baseline measures and study measures up to four times after each clinician visit.
Family Caregiver Self-efficacy (Exploratory)	—	—	0.1 change in score on a scale Standard Deviation 2.1	-0.7 change in score on a scale Standard Deviation 1.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and through first subsequent hospice visit, an average of 8 weeks

Population: Assessed in FCP only. No clinician data collected. Analyzed only for FCP who completed baseline and follow-up measures.

The investigators will assess caregiver preparedness for dementia caregiving using the validated, 8-item Preparedness Scale of the Family Care Inventory. Mean of 8 items ranges from 0-5, with higher scores indicating greater preparedness. The investigators will assess changes at baseline and the first subsequent hospice visit and compare differences in changes between the intervention and control groups. The same issues due to attrition described in 1. Family Caregiver burden above also apply here.

Outcome measures

Outcome measures
Measure	Intervention Clinicians IDTs were randomly assigned to intervention or control; clinician participants were assigned according to the randomization of their IDT. Intervention clinicians completed baseline measures, completed educational modules and corresponding measures, used the intervention tool up to four times with each enrolled FCP on their caseload, and completed a post-intervention measure.	Control Clinicians IDTs were randomly assigned to intervention or control; clinician participants were assigned according to the randomization of their IDT. Control clinicians completed baseline measures and listened to a 10-minute presentation on outcomes for Patients living with dementia in hospice. FCP on their caseloads received standard hospice care.	Intervention Family Care Partners (FCP) n=26 Participants FCPs were assigned to intervention or control based on the assignment of their clinician enrolled in the study. Intervention FCPs completed baseline measures and study measures up to four times after each clinician visit, including additional measures corresponding to the use of the tool which clinicians were instructed to use with them at each appropriate visit. They also completed a post-intervention measure.	Control Family Care Partners n=15 Participants FCPs were assigned to intervention or control based on the assignment of their clinician enrolled in the study. Control FCP received standard hospice care and completed baseline measures and study measures up to four times after each clinician visit.
Family Caregiver Preparedness (Exploratory)	—	—	0.1 change in score on a scale Standard Deviation 0.6	0.1 change in score on a scale Standard Deviation 0.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days post-intervention

Population: Assessed for hospice patient associated with FCP. Not assessed for clinicians.

The investigators will categorize the patient of study-enrolled FCPs into two categories based on their hospice enrollment status 90 days following study completion to determine number of patients who are discharged alive (category 1) compared to being deceased or still enrolled in hospice (category 2). This will be measured by looking at the "discharge status" variable in the electronic hospice records, which records patients as "enrolled," "discharged-deceased," or "discharged-live discharge." The investigators will count the number of patients in each category (discharged alive or enrolled/deceased) and compare results between intervention and control groups.

Outcome measures

Outcome measures
Measure	Intervention Clinicians IDTs were randomly assigned to intervention or control; clinician participants were assigned according to the randomization of their IDT. Intervention clinicians completed baseline measures, completed educational modules and corresponding measures, used the intervention tool up to four times with each enrolled FCP on their caseload, and completed a post-intervention measure.	Control Clinicians IDTs were randomly assigned to intervention or control; clinician participants were assigned according to the randomization of their IDT. Control clinicians completed baseline measures and listened to a 10-minute presentation on outcomes for Patients living with dementia in hospice. FCP on their caseloads received standard hospice care.	Intervention Family Care Partners (FCP) n=35 Participants FCPs were assigned to intervention or control based on the assignment of their clinician enrolled in the study. Intervention FCPs completed baseline measures and study measures up to four times after each clinician visit, including additional measures corresponding to the use of the tool which clinicians were instructed to use with them at each appropriate visit. They also completed a post-intervention measure.	Control Family Care Partners n=26 Participants FCPs were assigned to intervention or control based on the assignment of their clinician enrolled in the study. Control FCP received standard hospice care and completed baseline measures and study measures up to four times after each clinician visit.
Patient Hospice Discharge Status (Exploratory) Number of patients discharged alive (Category 1)	—	—	3 participants	3 participants
Patient Hospice Discharge Status (Exploratory) Number of patients deceased or still enrolled in hospice (Category 2).	—	—	32 participants	23 participants

Adverse Events

Intervention Clinicians

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Clinicians

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention Family Care Partners (FCP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Family Care Partners

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

Dr. Elizabeth Luth

Rutgers University

Phone: 732-235-7676

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place