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
|
|---|---|---|---|
|
Baseline Self-Reported Skin Behaviors
Keep skin clean and dry
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Baseline Self-Reported Skin Behaviors
Other
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 12.64 • n=5 Participants
|
49.75 years
STANDARD_DEVIATION 14.89 • n=7 Participants
|
50.67 years
STANDARD_DEVIATION 13.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Marital status
Divorced
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Marital status
Never married
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Marital status
Married
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Marital status
Widowed
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Residence type
House
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Residence type
Apartment
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Education
High school graduate
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Education
Some high school
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Education
Some college
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Education
College graduate
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Education
Graduate school
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Current employment status
Not working
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Current employment status
Small business owner
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Years Since Employment
|
10.43 years
n=5 Participants
|
14.64 years
n=7 Participants
|
12.12 years
n=5 Participants
|
|
Past Work History
Semi-skilled worker
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Past Work History
Never worked
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Past Work History
Unskilled worker
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Past Work History
Skilled manual worker, crafstman
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Past Work History
Clerical, sales worker
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Past Work History
Administrator, professional, manager
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Past Work History
Other
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Duration of Injury in years
|
17.94 years
n=5 Participants
|
18.81 years
n=7 Participants
|
18.4 years
n=5 Participants
|
|
Spinal Cord Injury (SCI) Etiology
Vehicular accident
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Spinal Cord Injury (SCI) Etiology
Diving
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Spinal Cord Injury (SCI) Etiology
Fall
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Spinal Cord Injury (SCI) Etiology
Gunshot wound
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Spinal Cord Injury (SCI) Etiology
Other etiology
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Level of Injury
Cervical
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Level of Injury
Thoracic
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Level of Injury
Lumbar
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Level of Injury
N/A
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
American Spinal Injury Association (ASIA) Score
A = Complete
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
American Spinal Injury Association (ASIA) Score
B = Sensory Incomplete
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
American Spinal Injury Association (ASIA) Score
C = Motor Incomplete
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
American Spinal Injury Association (ASIA) Score
D = Motor Incomplete
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
American Spinal Injury Association (ASIA) Score
Unknown
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Urinary Management
Intermittent Catheter
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Urinary Management
Condom Catheter
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Urinary Management
Other
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Urinary Management
Unknown
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Amputees
Right Lower Extremity
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Amputees
N/A
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Receive regular assistance from:
Spouse
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Receive regular assistance from:
Paid Attendant
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Receive regular assistance from:
Partner/Significant Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Receive regular assistance from:
Other Relatives
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Number of prior pressure ulcers (PrU)
|
2.43 pressure ulcers
n=5 Participants
|
1.7 pressure ulcers
n=7 Participants
|
2 pressure ulcers
n=5 Participants
|
|
Prior Ulcer Locations
Ischium
|
4 pressure ulcers
n=5 Participants
|
2 pressure ulcers
n=7 Participants
|
6 pressure ulcers
n=5 Participants
|
|
Prior Ulcer Locations
Trochanter
|
3 pressure ulcers
n=5 Participants
|
1 pressure ulcers
n=7 Participants
|
4 pressure ulcers
n=5 Participants
|
|
Prior Ulcer Locations
Sacrum
|
1 pressure ulcers
n=5 Participants
|
3 pressure ulcers
n=7 Participants
|
4 pressure ulcers
n=5 Participants
|
|
Prior Ulcer Locations
Coccyx
|
1 pressure ulcers
n=5 Participants
|
2 pressure ulcers
n=7 Participants
|
3 pressure ulcers
n=5 Participants
|
|
Prior Ulcer Locations
Heel
|
1 pressure ulcers
n=5 Participants
|
1 pressure ulcers
n=7 Participants
|
2 pressure ulcers
n=5 Participants
|
|
Prior Ulcer Locations
Lateral Malleolus
|
0 pressure ulcers
n=5 Participants
|
1 pressure ulcers
n=7 Participants
|
1 pressure ulcers
n=5 Participants
|
|
Prior Ulcer Locations
Medial Malleolus
|
0 pressure ulcers
n=5 Participants
|
1 pressure ulcers
n=7 Participants
|
1 pressure ulcers
n=5 Participants
|
|
Number of Prior Pressure Ulcer Surgeries
|
0.6 surgeries
n=5 Participants
|
0.63 surgeries
n=7 Participants
|
0.61 surgeries
n=5 Participants
|
|
Prior Ulcer Surgery Locations
Ischium
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Prior Ulcer Surgery Locations
Trochanter
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Prior Ulcer Surgery Locations
Sacrum
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Prior Ulcer Surgery Locations
Coccyx
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Prior Ulcer Surgery Locations
Lateral Malleolus
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Prior Ulcer Surgery Locations
N/A
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Number of Current Pressure Ulcers
|
1.2 pressure ulcers
n=5 Participants
|
0.5 pressure ulcers
n=7 Participants
|
0.89 pressure ulcers
n=5 Participants
|
|
Current Pressure Ulcer Location
Ischium
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Current Pressure Ulcer Location
Sacrum
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Current Pressure Ulcer Location
Other
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Current Pressure Ulcer Location
N/A
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Current Pressure Ulcer Stage
Stage I = Intact skin/non-blanchable redness
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Current Pressure Ulcer Stage
Stage II = Partial thickness
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Current Pressure Ulcer Stage
Stage III = Full thickness
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Current Pressure Ulcer Stage
Stage IV = Full thickness
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Current Pressure Ulcer Stage
Unknown
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Current Pressure Ulcer Stage
N/A
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Baseline Self-Reported Skin Behaviors
Daily Skin Inspection
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Baseline Self-Reported Skin Behaviors
Good Nutrition
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Baseline Self-Reported Skin Behaviors
Pressure releases/Tilts/Weight shifts
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Baseline Self-Reported Skin Behaviors
Hygiene
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Baseline Self-Reported Skin Behaviors
Appropriate Cushion
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Baseline Self-Reported Skin Behaviors
Safety in transfers
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Baseline Self-Reported Skin Behaviors
No tight clothing/shoes
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 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