Self-Management Program for Persons With Limb Loss

Depression Clinical Trial

Official title:

Randomized Clinical Trial of Self-Management Educational Program for Persons With Limb Loss.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198692
• Other study ID #: R04/CCU322981-02
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: October 27, 2008
• Start date: August 2003
• Est. completion date: March 2006

Study information

• Verified date: September 2005
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Approximately 1.2 million Americans are living with limb loss. Pain, psychological distress, reduced function and disability are common conditions following limb loss and are related to reduced quality of life. Our own work has identified depression, anxiety, and pain as significant problems for community dwelling persons with limb loss. Traditionally, interventions for disabling impairments and related secondary conditions focus on standard medical treatments such as medication, surgery or rehabilitative therapies. Self-management (SM) interventions, on the other hand, have been found to be effective in reducing secondary conditions and disability associated with some chronic conditions using individual and group-based delivery methods. To date, no SM intervention has been developed for, and evaluated in, persons with limb loss. The goal of the project is to develop and test the efficacy of a community-based self-management intervention for reducing pain, depression, and anxiety and improving positive mood, self-efficacy and function in persons with limb loss. The intervention will build on the already exisitng national network of community-based peer support groups developed by the Amputee Coalition of America (ACA). Establishing the efficacy of commmunity-based SM interventions for persons with limb loss has the potential to improve the health and quality of life for this population

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Persons with acquired or congenital limb loss

Exclusion Criteria:

• Non-English speakers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Amputation
• Anxiety
• Depression
• Pain

Intervention

Behavioral:
• self-management

Locations

Country	Name	City	State
United States	Johns Hopkins University Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Amputee Coalition of America, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measures are pain, anxiety, depression, and positive mood.
Secondary	Secondary outcome measures are restrictions in activities and participation and health related quality of life