AmputationNCT00198692
Self-Management Program for Persons With Limb Loss
A study testing self-management in people with Amputation and Depression, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Amputation, Depression, Pain
- What is being tested?
- self-management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Mar 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons with acquired or congenital limb loss
Who cannot join
- Non-English speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: Randomized Clinical Trial of Self-Management Educational Program for Persons With Limb Loss.
The specific aims of this study are:
- 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.
- 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.
- 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.
Read the 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
- Conditions
- Amputation, Depression, Pain, Anxiety
- Being tested
- self-management
- Keywords
- amputation, depression, pain, anxiety, self-management, secondary conditions
- Medical subject headings
- Depression, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-managementBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2003
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Amputee Coalition of America
- Investigators
- Ellen J MacKenzie, PhD, Principal investigator, Johns Hopkins University Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198692
- Sponsor's protocol ID
- R04/CCU322981-02
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 28 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Self-Management Educational Program for Persons With Limb Loss.
- ClinicalTrials.gov ID
- NCT00198692
- Acronym / sponsor ID
- R04/CCU322981-02
- Conditions
- Amputation, Depression, Pain, Anxiety
- Keywords
- amputation, depression, pain, anxiety, self-management, secondary conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- University of Washington, Amputee Coalition of America
- Study start
- Aug 2003
- Study completion
- Mar 2006
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aims of this study are:
- 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.
- 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.
- 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.
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 design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persons with acquired or congenital limb loss
Key exclusion criteria (1 listed)
- Non-English speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-management | Behavioural | – |
Primary outcome
The primary outcome measures are pain, anxiety, depression, and positive mood.
1 secondary outcome
Secondary outcome measures are restrictions in activities and participation and health related quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2008.
- Promoting Amputee Life Skills Study SiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen J MacKenzie, PhD principal investigator
Johns Hopkins University Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-management in people with Amputation and Depression, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measures are pain, anxiety, depression, and positive mood.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2008.