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Completed

NCT Number: NCT00198692

Self-Management 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.

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Key information

Conditions

Amputation Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persons with acquired or congenital limb loss

Exclusion criteria

  • Non-English speakers

Treatment and study plan

Self-Management

Behavioral

Primary outcomes

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

Secondary outcomes

  1. Secondary outcome measures are restrictions in activities and participation and health related quality of life

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Amputee Coalition of America
  • University of Washington

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Oct 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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