Self-Management Program for Persons With Limb Loss

October 27, 2008 updated by: Johns Hopkins Bloomberg School of Public Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University Bloomberg School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Persons with acquired or congenital limb loss

Exclusion Criteria:

  • Non-English speakers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary outcome measures are pain, anxiety, depression, and positive mood.

Secondary Outcome Measures

Outcome Measure
Secondary outcome measures are restrictions in activities and participation and health related quality of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

University of Washington
Amputee Coalition of America

Investigators

  • Principal Investigator: Ellen J MacKenzie, PhD, Johns Hopkins University Bloomberg School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

October 28, 2008

Last Update Submitted That Met QC Criteria

October 27, 2008

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R04/CCU322981-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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