Self-Management Program for Persons With Limb Loss
Completed · Not applicable
Conditions studied: Amputation, Depression, Pain, Anxiety
In brief
The specific aims of this study are: 1. To develop and pilot a self-management (SM) intervention for persons with limb loss in a group setting using a participatory action research (PAR) strategy. 2. To evaluate the feasiablity and effectiveness of a SM intervention within the context of the existng network of limb loss peer support groups Hypothesis #2a: The SM intervention groups will be more effective than standard support group activities in reducing pain, depression and anxiety, and increasing positive mood and improving function and overall quality of life. Hypothesis #2b: Improvements in pain, depression, anxiety, function and quality of life will correlate strongly with improvements in self-efficacy, catastrophizing, and satisfaction with the prosthesis and prosthetic services. Hypothesis #2c: Gains in outcome will be maintained for one year. Hypothesis #2d: Characteristics of study participants and their environment (i.e. sociodemographics, co-morbidities, economic and educational resources, hope, and social support) will correlate with outcome and mediate the effect of the intervention. 3. To determine the costs of the intervention and examine the relationship between costs and effectiveness. Hypothesis #3a: When compared to the control support group, the SM intervention will be cost-effective in terms of gains in quality adjusted years of life.
Key facts
- Study ID
- NCT00198692
- Run by
- Johns Hopkins Bloomberg School of Public Health
- People needed
- 500
- Starts
- 2003-08-01
- Expected to finish
- 2006-03-01
- Last updated by the study team
- 2008-10-28
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Persons with acquired or congenital limb loss
You may not qualify if…
- Non-English speakers
Where it is running
- Johns Hopkins University Bloomberg School of Public Health — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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