Trial Outcomes & Findings for Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D (NCT NCT00624806)
NCT ID: NCT00624806
Last Updated: 2015-04-28
Results Overview
Data includes the number of triggered items and types of triggers.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Enrollment to study end, 8 weeks
Results posted on
2015-04-28
Participant Flow
Participant milestones
| Measure |
Arm 1
Daily telephone calls to remind patients of recommended behaviors
Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.
|
Arm 2
Weekly telephone calls to remind patients of recommended behaviors
Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D
Baseline characteristics by cohort
| Measure |
Daily Group
n=10 Participants
Daily telephone calls to remind patients of recommended behaviors
Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.
|
Weekly Group
n=8 Participants
Weekly telephone calls to remind patients of recommended behaviors
Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 12.64 • n=99 Participants
|
49.75 years
STANDARD_DEVIATION 14.89 • n=107 Participants
|
50.67 years
STANDARD_DEVIATION 13.29 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Marital status
Divorced
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Marital status
Never married
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Marital status
Married
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Marital status
Widowed
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Residence type
House
|
8 participants
n=99 Participants
|
6 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Residence type
Apartment
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Education
High school graduate
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Education
Some high school
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Education
Some college
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Education
College graduate
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Education
Graduate school
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Current employment status
Not working
|
10 participants
n=99 Participants
|
7 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Current employment status
Small business owner
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Years Since Employment
|
10.43 years
n=99 Participants
|
14.64 years
n=107 Participants
|
12.12 years
n=206 Participants
|
|
Past Work History
Semi-skilled worker
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Past Work History
Never worked
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Past Work History
Unskilled worker
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Past Work History
Skilled manual worker, crafstman
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Past Work History
Clerical, sales worker
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Past Work History
Administrator, professional, manager
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Past Work History
Other
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Duration of Injury in years
|
17.94 years
n=99 Participants
|
18.81 years
n=107 Participants
|
18.4 years
n=206 Participants
|
|
Spinal Cord Injury (SCI) Etiology
Vehicular accident
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Spinal Cord Injury (SCI) Etiology
Diving
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Spinal Cord Injury (SCI) Etiology
Fall
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Spinal Cord Injury (SCI) Etiology
Gunshot wound
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Spinal Cord Injury (SCI) Etiology
Other etiology
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Level of Injury
Cervical
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Level of Injury
Thoracic
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Level of Injury
Lumbar
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Level of Injury
N/A
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
American Spinal Injury Association (ASIA) Score
A = Complete
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
American Spinal Injury Association (ASIA) Score
B = Sensory Incomplete
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
American Spinal Injury Association (ASIA) Score
C = Motor Incomplete
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
American Spinal Injury Association (ASIA) Score
D = Motor Incomplete
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
American Spinal Injury Association (ASIA) Score
Unknown
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Urinary Management
Intermittent Catheter
|
2 participants
n=99 Participants
|
6 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Urinary Management
Condom Catheter
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Urinary Management
Other
|
5 participants
n=99 Participants
|
1 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Urinary Management
Unknown
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Amputees
Right Lower Extremity
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Amputees
N/A
|
9 participants
n=99 Participants
|
7 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Receive regular assistance from:
Spouse
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Receive regular assistance from:
Paid Attendant
|
5 participants
n=99 Participants
|
3 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Receive regular assistance from:
Partner/Significant Other
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Receive regular assistance from:
Other Relatives
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Number of prior pressure ulcers (PrU)
|
2.43 pressure ulcers
n=99 Participants
|
1.7 pressure ulcers
n=107 Participants
|
2 pressure ulcers
n=206 Participants
|
|
Prior Ulcer Locations
Ischium
|
4 pressure ulcers
n=99 Participants
|
2 pressure ulcers
n=107 Participants
|
6 pressure ulcers
n=206 Participants
|
|
Prior Ulcer Locations
Trochanter
|
3 pressure ulcers
n=99 Participants
|
1 pressure ulcers
n=107 Participants
|
4 pressure ulcers
n=206 Participants
|
|
Prior Ulcer Locations
Sacrum
|
1 pressure ulcers
n=99 Participants
|
3 pressure ulcers
n=107 Participants
|
4 pressure ulcers
n=206 Participants
|
|
Prior Ulcer Locations
Coccyx
|
1 pressure ulcers
n=99 Participants
|
2 pressure ulcers
n=107 Participants
|
3 pressure ulcers
n=206 Participants
|
|
Prior Ulcer Locations
Heel
|
1 pressure ulcers
n=99 Participants
|
1 pressure ulcers
n=107 Participants
|
2 pressure ulcers
n=206 Participants
|
|
Prior Ulcer Locations
Lateral Malleolus
|
0 pressure ulcers
n=99 Participants
|
1 pressure ulcers
n=107 Participants
|
1 pressure ulcers
n=206 Participants
|
|
Prior Ulcer Locations
Medial Malleolus
|
0 pressure ulcers
n=99 Participants
|
1 pressure ulcers
n=107 Participants
|
1 pressure ulcers
n=206 Participants
|
|
Number of Prior Pressure Ulcer Surgeries
|
0.6 surgeries
n=99 Participants
|
0.63 surgeries
n=107 Participants
|
0.61 surgeries
n=206 Participants
|
|
Prior Ulcer Surgery Locations
Ischium
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Prior Ulcer Surgery Locations
Trochanter
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Prior Ulcer Surgery Locations
Sacrum
|
0 participants
n=99 Participants
|
4 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Prior Ulcer Surgery Locations
Coccyx
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Prior Ulcer Surgery Locations
Lateral Malleolus
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Prior Ulcer Surgery Locations
N/A
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Number of Current Pressure Ulcers
|
1.2 pressure ulcers
n=99 Participants
|
0.5 pressure ulcers
n=107 Participants
|
0.89 pressure ulcers
n=206 Participants
|
|
Current Pressure Ulcer Location
Ischium
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Current Pressure Ulcer Location
Sacrum
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Current Pressure Ulcer Location
Other
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Current Pressure Ulcer Location
N/A
|
7 participants
n=99 Participants
|
4 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Current Pressure Ulcer Stage
Stage I = Intact skin/non-blanchable redness
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Current Pressure Ulcer Stage
Stage II = Partial thickness
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Current Pressure Ulcer Stage
Stage III = Full thickness
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Current Pressure Ulcer Stage
Stage IV = Full thickness
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Current Pressure Ulcer Stage
Unknown
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Current Pressure Ulcer Stage
N/A
|
7 participants
n=99 Participants
|
4 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Baseline Self-Reported Skin Behaviors
Daily Skin Inspection
|
8 participants
n=99 Participants
|
4 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Baseline Self-Reported Skin Behaviors
Good Nutrition
|
9 participants
n=99 Participants
|
5 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Baseline Self-Reported Skin Behaviors
Pressure releases/Tilts/Weight shifts
|
9 participants
n=99 Participants
|
4 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Baseline Self-Reported Skin Behaviors
Hygiene
|
8 participants
n=99 Participants
|
5 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Baseline Self-Reported Skin Behaviors
Appropriate Cushion
|
7 participants
n=99 Participants
|
2 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Baseline Self-Reported Skin Behaviors
Safety in transfers
|
7 participants
n=99 Participants
|
3 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Baseline Self-Reported Skin Behaviors
No tight clothing/shoes
|
8 participants
n=99 Participants
|
5 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Baseline Self-Reported Skin Behaviors
Keep skin clean and dry
|
9 participants
n=99 Participants
|
5 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Baseline Self-Reported Skin Behaviors
Other
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Enrollment to study end, 8 weeksData includes the number of triggered items and types of triggers.
Outcome measures
| Measure |
Arm 1
n=10 Participants
Daily telephone calls to remind patients of recommended behaviors
Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.
|
Arm 2
n=8 Participants
Weekly telephone calls to remind patients of recommended behaviors
Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.
|
|---|---|---|
|
Days of Data
|
9 days
Interval 1.0 to 18.0
|
7 days
Interval 1.0 to 10.0
|
PRIMARY outcome
Timeframe: Enrollment to study end, 8 weeksMeasured the number of days with triggers that occurred on the Baseline day, during the 8-week intervention, and on the End of Study day.
Outcome measures
| Measure |
Arm 1
n=30 No. of Days with Triggers
Daily telephone calls to remind patients of recommended behaviors
Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.
|
Arm 2
n=34 No. of Days with Triggers
Weekly telephone calls to remind patients of recommended behaviors
Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.
|
|---|---|---|
|
Number of Days With Triggers at Certain Timeframe
Baseline Day Triggers
|
5 days
|
6 days
|
|
Number of Days With Triggers at Certain Timeframe
Days with Triggers during Intervention
|
24 days
|
24 days
|
|
Number of Days With Triggers at Certain Timeframe
End of Study Day Triggers
|
1 days
|
4 days
|
PRIMARY outcome
Timeframe: Enrollment to study end, 8 weeksPercent of participants who triggered Disease-Management Protocol items by group.
Outcome measures
| Measure |
Arm 1
n=39 Total Days of Category Trigger
Daily telephone calls to remind patients of recommended behaviors
Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.
|
Arm 2
n=70 Total Days of Category Trigger
Weekly telephone calls to remind patients of recommended behaviors
Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.
|
|---|---|---|
|
Percent of Participant Triggering DMP Items
Daily Skin Inspection
|
23.3 % of participants triggering an item
|
23.5 % of participants triggering an item
|
|
Percent of Participant Triggering DMP Items
Equipment Issues
|
40 % of participants triggering an item
|
55.9 % of participants triggering an item
|
|
Percent of Participant Triggering DMP Items
Positioning/Pressure Reliefs/Weight Shifts
|
46.7 % of participants triggering an item
|
50 % of participants triggering an item
|
|
Percent of Participant Triggering DMP Items
Skin Moisture Issues
|
0 % of participants triggering an item
|
11.8 % of participants triggering an item
|
|
Percent of Participant Triggering DMP Items
Existing Pressure Ulcer Care
|
0 % of participants triggering an item
|
17.6 % of participants triggering an item
|
|
Percent of Participant Triggering DMP Items
Quality of CG Care
|
3.3 % of participants triggering an item
|
8.8 % of participants triggering an item
|
|
Percent of Participant Triggering DMP Items
Feelings of Depression
|
0 % of participants triggering an item
|
11.8 % of participants triggering an item
|
|
Percent of Participant Triggering DMP Items
Ongoing Problems Affecting Self-Mgmt
|
6.7 % of participants triggering an item
|
14.7 % of participants triggering an item
|
|
Percent of Participant Triggering DMP Items
Dragging Across Surfaces
|
3.3 % of participants triggering an item
|
8.8 % of participants triggering an item
|
|
Percent of Participant Triggering DMP Items
Diabetic Comorbidities
|
6.7 % of participants triggering an item
|
2.9 % of participants triggering an item
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
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
Marylou Guihan, PhD
Center of Innovation for Complex Chronic Health Care
Phone: 708-202-2414
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place