Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00624806
• Collaborator: (none)
• Enrollment: 18
• Locations: 2
• Arms: 2
• Duration (Months): 21
• Patients Per Site: 9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The Veteran's Health Administration (VHA) is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (DMPs). No such DMPs exist for the community dwelling spinal cord injury/disorders (SCI/D) population. Our objective is to develop the tools necessary for implementing a new home telehealth program to manage community-dwelling veterans with SCI/D at high risk of developing pressure ulcers (PrUs).

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury	Behavioral: Daily telephone calls; Behavioral: Weekly telephone calls	N/A

Detailed Description

Background:

VHA is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (DMPs). No such DMPs exist for the community dwelling spinal cord injury/disorders (SCI/D) population. Our objective is to develop the tools necessary for implementing a new home telehealth program to manage community-dwelling veterans with SCI/D at high risk of developing pressure ulcers (PrUs).

Objectives:

The goal of the study was to complete activities necessary in preparation for implementing a Home Telehealth program to manage veterans with SCI/D at risk of developing PrUs. Specifically this Rapid Response Project (RRP) included: 1) Convening an expert panel to validate Pressure Ulcer (PrU) PrU DMP items; 2) Developing a standardized protocol that specified how the nurse Care Coordinator who would manage patients who develop open skin wounds across the Hub and Spoke system of care; 3) Assessing individual telehealth DMP items by calling a sample of patients on a daily or weekly basis for up to 2 months to determine their validity and 4) Developing an instrument to assess staff satisfaction with this method of patient management.

Methods:

A convenience sample of veterans about to be discharged home from the Cleveland SCI/D inpatient unit were asked to participate in the study. This included patients living close to the Hub and those referred from spoke sites. Subjects were randomly assigned to receive either daily calls (5 days/week) for 40 total calls, or weekly calls (8 total calls) over the course of the 8 week/2month study intervention period.

Status:

The project team is conducting ongoing analysis of the data to develop publications.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Daily telephone calls Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers	Behavioral: Daily telephone calls; Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.
Active Comparator: Weekly telephone calls Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.	Behavioral: Weekly telephone calls; Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.

Outcome Measures

Primary Outcome Measures

1. Days of Data [Enrollment to study end, 8 weeks]

   Data includes the number of triggered items and types of triggers.

2. Number of Days With Triggers at Certain Timeframe [Enrollment to study end, 8 weeks]

   Measured the number of days with triggers that occurred on the Baseline day, during the 8-week intervention, and on the End of Study day.

3. Percent of Participant Triggering DMP Items [Enrollment to study end, 8 weeks]

   Percent of participants who triggered Disease-Management Protocol items by group.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Veterans admitted to Cleveland VA SCI/D unit or treated in the outpatient clinic

Exclusion Criteria:

• No phone

• Cognitive impairment

• Hearing impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Edward Hines Jr. VA Hospital, Hines, IL	Hines	Illinois	United States	60141-5000
2	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Marylou Guihan, PhD MA BA, Edward Hines Jr. VA Hospital, Hines, IL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00624806
• Other Study ID Numbers: RRP 07-292
• First Posted: Feb 27, 2008
• Last Update Posted: Apr 28, 2015
• Last Verified: Jul 1, 2014

• Keywords provided by US Department of Veterans Affairs: Pressure ulcer; Telemedicine
• Additional relevant MeSH terms: Spinal Cord Injuries; Pressure Ulcer

Study Results

Participant Flow

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	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 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.
Period Title: Overall Study
STARTED	10	8
COMPLETED	10	8
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Daily Group	Weekly Group	Total
Arm/Group Description	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 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 of all reporting groups
Overall Participants	10	8	18
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.4 (12.64)	49.75 (14.89)	50.67 (13.29)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	10 100%	8 100%	18 100%
Race/Ethnicity, Customized (participants) [Number]
White	6 60%	6 75%	12 66.7%
Black	4 40%	2 25%	6 33.3%
Marital status (participants) [Number]
Divorced	4 40%	3 37.5%	7 38.9%
Never married	3 30%	2 25%	5 27.8%
Married	2 20%	3 37.5%	5 27.8%
Widowed	1 10%	0 0%	1 5.6%
Residence type (participants) [Number]
House	8 80%	6 75%	14 77.8%
Apartment	2 20%	2 25%	4 22.2%
Education (participants) [Number]
High school graduate	4 40%	2 25%	6 33.3%
Some high school	1 10%	1 12.5%	2 11.1%
Some college	3 30%	2 25%	5 27.8%
College graduate	1 10%	0 0%	1 5.6%
Graduate school	1 10%	3 37.5%	4 22.2%
Current employment status (participants) [Number]
Not working	10 100%	7 87.5%	17 94.4%
Small business owner	0 0%	1 12.5%	1 5.6%
Years Since Employment (years) [Mean (Full Range) ]
Mean (Full Range) [years]	10.43	14.64	12.12
Past Work History (participants) [Number]
Semi-skilled worker	2 20%	2 25%	4 22.2%
Never worked	0 0%	1 12.5%	1 5.6%
Unskilled worker	2 20%	0 0%	2 11.1%
Skilled manual worker, crafstman	1 10%	1 12.5%	2 11.1%
Clerical, sales worker	2 20%	0 0%	2 11.1%
Administrator, professional, manager	2 20%	1 12.5%	3 16.7%
Other	1 10%	3 37.5%	4 22.2%
Duration of Injury in years (years) [Mean (Full Range) ]
Mean (Full Range) [years]	17.94	18.81	18.4
Spinal Cord Injury (SCI) Etiology (participants) [Number]
Vehicular accident	5 50%	2 25%	7 38.9%
Diving	0 0%	1 12.5%	1 5.6%
Fall	1 10%	2 25%	3 16.7%
Gunshot wound	1 10%	2 25%	3 16.7%
Other etiology	3 30%	1 12.5%	4 22.2%
Level of Injury (participants) [Number]
Cervical	6 60%	6 75%	12 66.7%
Thoracic	1 10%	2 25%	3 16.7%
Lumbar	1 10%	0 0%	1 5.6%
N/A	2 20%	0 0%	2 11.1%
American Spinal Injury Association (ASIA) Score (participants) [Number]
A = Complete	3 30%	4 50%	7 38.9%
B = Sensory Incomplete	2 20%	2 25%	4 22.2%
C = Motor Incomplete	1 10%	1 12.5%	2 11.1%
D = Motor Incomplete	1 10%	1 12.5%	2 11.1%
Unknown	3 30%	0 0%	3 16.7%
Urinary Management (participants) [Number]
Intermittent Catheter	2 20%	6 75%	8 44.4%
Condom Catheter	2 20%	0 0%	2 11.1%
Other	5 50%	1 12.5%	6 33.3%
Unknown	1 10%	1 12.5%	2 11.1%
Amputees (participants) [Number]
Right Lower Extremity	1 10%	1 12.5%	2 11.1%
N/A	9 90%	7 87.5%	16 88.9%
Receive regular assistance from: (participants) [Number]
Spouse	2 20%	3 37.5%	5 27.8%
Paid Attendant	5 50%	3 37.5%	8 44.4%
Partner/Significant Other	1 10%	1 12.5%	2 11.1%
Other Relatives	2 20%	1 12.5%	3 16.7%
Number of prior pressure ulcers (PrU) (pressure ulcers) [Mean (Full Range) ]
Mean (Full Range) [pressure ulcers]	2.43	1.7	2
Prior Ulcer Locations (pressure ulcers) [Number]
Ischium	4	2	6
Trochanter	3	1	4
Sacrum	1	3	4
Coccyx	1	2	3
Heel	1	1	2
Lateral Malleolus	0	1	1
Medial Malleolus	0	1	1
Number of Prior Pressure Ulcer Surgeries (surgeries) [Mean (Full Range) ]
Mean (Full Range) [surgeries]	0.6	0.63	0.61
Prior Ulcer Surgery Locations (participants) [Number]
Ischium	3 30%	1 12.5%	4 22.2%
Trochanter	1 10%	0 0%	1 5.6%
Sacrum	0 0%	4 50%	4 22.2%
Coccyx	1 10%	0 0%	1 5.6%
Lateral Malleolus	0 0%	1 12.5%	1 5.6%
N/A	5 50%	2 25%	7 38.9%
Number of Current Pressure Ulcers (pressure ulcers) [Mean (Full Range) ]
Mean (Full Range) [pressure ulcers]	1.2	0.5	0.89
Current Pressure Ulcer Location (participants) [Number]
Ischium	2 20%	0 0%	2 11.1%
Sacrum	1 10%	2 25%	3 16.7%
Other	0 0%	2 25%	2 11.1%
N/A	7 70%	4 50%	11 61.1%
Current Pressure Ulcer Stage (participants) [Number]
Stage I = Intact skin/non-blanchable redness	0 0%	2 25%	2 11.1%
Stage II = Partial thickness	0 0%	0 0%	0 0%
Stage III = Full thickness	0 0%	1 12.5%	1 5.6%
Stage IV = Full thickness	2 20%	1 12.5%	3 16.7%
Unknown	1 10%	0 0%	1 5.6%
N/A	7 70%	4 50%	11 61.1%
Baseline Self-Reported Skin Behaviors (participants) [Number]
Daily Skin Inspection	8 80%	4 50%	12 66.7%
Good Nutrition	9 90%	5 62.5%	14 77.8%
Pressure releases/Tilts/Weight shifts	9 90%	4 50%	13 72.2%
Hygiene	8 80%	5 62.5%	13 72.2%
Appropriate Cushion	7 70%	2 25%	9 50%
Safety in transfers	7 70%	3 37.5%	10 55.6%
No tight clothing/shoes	8 80%	5 62.5%	13 72.2%
Keep skin clean and dry	9 90%	5 62.5%	14 77.8%
Other	2 20%	0 0%	2 11.1%

Outcome Measures

1. Primary Outcome

Title	Days of Data
Description	Data includes the number of triggered items and types of triggers.
Time Frame	Enrollment to study end, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	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 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.
Measure Participants	10	8
Mean (Full Range) [days]	9	7

2. Primary Outcome

Title	Number of Days With Triggers at Certain Timeframe
Description	Measured the number of days with triggers that occurred on the Baseline day, during the 8-week intervention, and on the End of Study day.
Time Frame	Enrollment to study end, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	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 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.
Measure Participants	10	8
Measure No. of Days with Triggers	30	34
Baseline Day Triggers	5	6
Days with Triggers during Intervention	24	24
End of Study Day Triggers	1	4

3. Primary Outcome

Title	Percent of Participant Triggering DMP Items
Description	Percent of participants who triggered Disease-Management Protocol items by group.
Time Frame	Enrollment to study end, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	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 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.
Measure Participants	10	8
Measure Total Days of Category Trigger	39	70
Daily Skin Inspection	23.3 233%	23.5 293.8%
Equipment Issues	40 400%	55.9 698.8%
Positioning/Pressure Reliefs/Weight Shifts	46.7 467%	50 625%
Skin Moisture Issues	0 0%	11.8 147.5%
Existing Pressure Ulcer Care	0 0%	17.6 220%
Quality of CG Care	3.3 33%	8.8 110%
Feelings of Depression	0 0%	11.8 147.5%
Ongoing Problems Affecting Self-Mgmt	6.7 67%	14.7 183.8%
Dragging Across Surfaces	3.3 33%	8.8 110%
Diabetic Comorbidities	6.7 67%	2.9 36.3%

Adverse Events

Time Frame	Enrollment to study end, 8 weeks.
Adverse Event Reporting Description	Study-related serious and non-serious adverse events were collected/assessed, but none observed.
Arm/Group Title	Arm 1		Arm 2
Arm/Group Description	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. No adverse events reported.		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. No adverse events reported.
All Cause Mortality
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/8 (0%)

Limitations/Caveats

The study duration was short and the sample was small. Because we only studied subjects who received the DMP, it is unknown how many would have had skin breakdown in a comparable period without the DMP.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.