Physical DisabilityPhase 1NCT00164476
Promoting Clinical Preventive Services Among Adults With Disabilities
A Phase 1 study testing Preventive Services Prevention Kit in people with Physical Disability, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
Project SHIELD (Strategies and health Interventions to Enhance Life with Disability) is a participatory action research project to test an intervention package combining a resource kit with peer mentoring in improving consumer education about primary preventive services Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Physical Disability
- What is being tested?
- Preventive Services Prevention Kit
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Jun 2005
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary residence in Northern Virginia presence of a physical disability at least 18 years old
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
National Rehabilitation Hospital
Washington D.C., District of Columbia, 20019
About this study
Official title: Promoting Prevention Among Adults With Disabilities
Project SHIELD (Strategies and health Interventions to Enhance Life with Disability) is a participatory action research project to test an intervention package combining a resource kit with peer mentoring in improving consumer education about primary preventive services
Read the detailed description
Adults with disabilities use primary preventive health care services (basic screenings, immunizations, and hevior health counseling) at rates below those recommended by the US Preventive Services Task Force and Healthy People 2010. This projects is to carry out a community-based campaign to increase preventive care knowledge and service use among adults with physical disabilities. Focus group methodology will be used to determine the specific preventive service priorities of the disability community so that targeted resource materials for consumers and physicians can be developed. Second, a randomized control group experiment will be implemented to evaluate the effectiveness of the targeted resource materials, followed by dissemination of the Preventive Services Resource Kits.
- Conditions
- Physical Disability
- Being tested
- Preventive Services Prevention Kit, peer mentors (control group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive Services Prevention KitBehavioural
peer mentors (control group)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention-related knowledge and beliefs
Self-efficacy
Service-seeking intent
Service utilization
Secondary outcomes (1)
perceptions of the Preventive Service Resource Kit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startOct 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Investigators
- Suzanne L Groah, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164476
- Sponsor's protocol ID
- CDC-NCBDDD-CCR323280
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 14 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Prevention Among Adults With Disabilities
- ClinicalTrials.gov ID
- NCT00164476
- Acronym / sponsor ID
- CDC-NCBDDD-CCR323280
- Conditions
- Physical Disability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Oct 2003
- Study completion
- Jun 2005
- First posted
- 14 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.
Project SHIELD (Strategies and health Interventions to Enhance Life with Disability) is a participatory action research project to test an intervention package combining a resource kit with peer mentoring in improving consumer education about primary preventive services
Detailed description
Adults with disabilities use primary preventive health care services (basic screenings, immunizations, and hevior health counseling) at rates below those recommended by the US Preventive Services Task Force and Healthy People 2010. This projects is to carry out a community-based campaign to increase preventive care knowledge and service use among adults with physical disabilities. Focus group methodology will be used to determine the specific preventive service priorities of the disability community so that targeted resource materials for consumers and physicians can be developed. Second, a randomized control group experiment will be implemented to evaluate the effectiveness of the targeted resource materials, followed by dissemination of the Preventive Services Resource Kits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary residence in Northern Virginia presence of a physical disability at least 18 years old
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Preventive Services Prevention Kit | Behavioural | – |
| peer mentors (control group) | Behavioural | – |
Primary outcome
Prevention-related knowledge and beliefs
Self-efficacy
Service-seeking intent
Service utilization
1 secondary outcome
perceptions of the Preventive Service Resource Kit
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 14 Sep 2005.
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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.
Suzanne L Groah, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Preventive Services Prevention Kit in people with Physical Disability, run by Centers for Disease Control and Prevention 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 14 Sep 2005. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Prevention-related knowledge and beliefs. The study lists 4 primary outcomes in all. 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 14 Sep 2005.