NCT00198692

Brief Summary

The specific aims of this study are:

  1. 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. 2.To evaluate the feasiablity and effectiveness of a SM intervention within the context of the existng network of limb loss peer support groups
  3. 3.To determine the costs of the intervention and examine the relationship between costs and effectiveness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

October 28, 2008

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

October 27, 2008

Conditions

AmputationDepressionPainAnxiety

Keywords

amputationdepressionpainanxietyself-managementsecondary conditions

Outcome Measures

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

Interventions

self-managementBEHAVIORAL

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons with acquired or congenital limb loss

You may not qualify if:

  • Non-English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Links

MeSH Terms

Conditions

DepressionPainAnxiety Disorders

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ellen J MacKenzie, PhD

    Johns Hopkins University Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

August 1, 2003

Study Completion

March 1, 2006

Last Updated

October 28, 2008

Record last verified: 2005-09

Locations

US(1)