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NCT00198692 · ClinicalTrials.gov registry record · NA

Self-Management Program for Persons With Limb Loss

A NA study of Depression and Pain, sponsored by Johns Hopkins Bloomberg School of Public Health.

Completed
Registry status
NA
Development phase
500
Enrollment target
1
Study location

NCT00198692 is a NA study of Depression and Pain that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 500 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (36% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00198692, a NA study of Depression and Pain, has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.

COMPLETED
Registry status
NA
Development phase
500 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • BEHAVIORAL self-management

Study Locations (1)

Maryland

  • Johns Hopkins University Bloomberg School of Public Health - Baltimore

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2003-08
Est. Completion 2006-03
Phase NA

What the Registry Record Tells You About NCT00198692

The ClinicalTrials.gov registry entry for NCT00198692 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (36% lower). The listed sponsor is Johns Hopkins Bloomberg School of Public Health, which has 187 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which self-management is the first listed.

NCT00198692 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00198692 about?

NCT00198692 is a clinical study titled "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 existn...

What is the current status of trial NCT00198692?

This trial is currently completed. It is a NA study. The enrollment target is 500 participants. The study started on 2003-08. Estimated completion is 2006-03.

What conditions does trial NCT00198692 study?

This clinical trial studies the following conditions: Depression, Pain, Anxiety, Amputation.

What interventions are being tested in trial NCT00198692?

The interventions under investigation include: self-management (BEHAVIORAL).

Who is sponsoring clinical trial NCT00198692?

This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00198692 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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