- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02916758
Promoting Community Mobility for Wellness in Older Adults in Urban Environments
September 23, 2016 updated by: Claire M. Mulry, OTD, OTR, CAPS, Kean University
Let's Go: Promoting Community Mobility for Wellness in Older Adults in Urban Environments
This study evaluates the program outcomes of the Let's Go program.
The standardized community mobility program employs multi-modal group and individual sessions to facilitate wellness in older adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study examines the outcomes of Let's Go, a standardized community mobility program which employs group and individual sessions of education, peer interaction, engagement in meaningful occupations, and self-reflections to help individuals understand the importance of community participation and its relationship to well-being.
Program outcomes explored include increased confidence in community mobility, increased autonomy outdoors, social life and relationships, frequency of community trips, and decreased social isolation.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Union, New Jersey, United States, 07083
- Kean University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Community dwelling individual
- Report desire to learn about community mobility options
- Able to participate in group education sessions (
- Able to attend during a 45 minute session
- Independent mobility in community with or without an assistive device.
Exclusion Criteria:
- Individual lives in Long Term Care facility
- Aphasia
- Individual has impaired cognition demonstrated by MoCA exam score ≤ 17
- Individual is unable to stay awake for entire group session
- Individual acts out (yelling, monopolizes, motor restlessness or agitation) in group setting.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Let's Go Community Mobility Program
Participation in 4 week program
|
Four week multi-modal education and experiential program to improve community mobilty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Impact on Participation and Autonomy Questionnaire-Autonomy Outdoors Sub scale
Time Frame: Baseline, 4 weeks (program end), 6 month follow up
|
The IPAQ measures an individual's perception of the impact of chronic disability on participation, has good responsiveness and its content, construct, and discriminant validity as well as internal consistency are deemed adequate and verified by Rasch analysis (Magasi & Post, 2010).
The content validity of the autonomy outdoors subscale (α = .81)
and social life and relationships scale (α = .86)
are strong.
Internal reliability of the IPAQ on all subscales is high (all Cronbach's alphas >0.8).
The individual items on the AO subscale have a test-retest reliability ranging from .69 to .84 and those on the SL subscale ranged from Kw = .71
to .77
(Cardol et al., 1999, Sibley et al., 2006).
|
Baseline, 4 weeks (program end), 6 month follow up
|
|
Change in Impact on Participation and Autonomy Questionnaire- Social Life and Relationships Sub scale
Time Frame: Baseline, 4 weeks (program end), 6 month follow up
|
The IPAQ measures an individual's perception of the impact of chronic disability on participation, has good responsiveness and its content, construct, and discriminant validity as well as internal consistency are deemed adequate and verified by Rasch analysis (Magasi & Post, 2010).
The content validity of the autonomy outdoors subscale (α = .81)
and social life and relationships scale (α = .86)
are strong.
Internal reliability of the IPAQ on all subscales is high (all Cronbach's alphas >0.8).
The individual items on the AO subscale have a test-retest reliability ranging from .69 to .84 and those on the SL subscale ranged from Kw = .71
to .77
(Cardol et al., 1999, Sibley et al., 2006).
|
Baseline, 4 weeks (program end), 6 month follow up
|
|
Change in Frequency of community trips per month
Time Frame: Baseline, 4 weeks (program end), 6 month follow up
|
A Participant Survey was developed by the Primary Investigator in which participants self reported the frequency of community trips in the past 30 days
|
Baseline, 4 weeks (program end), 6 month follow up
|
|
Change in Confidence in community mobility
Time Frame: Baseline, 4 weeks (program end), 6 month follow up
|
A Participant Survey was developed by the Primary Investigator in which participants self reported their confidence in community mobility on a Likert Scale
|
Baseline, 4 weeks (program end), 6 month follow up
|
|
Change in Self report of feelings of isolation
Time Frame: Baseline, 4 weeks (program end), 6 month follow up
|
A Participant Survey was developed by the Primary Investigator in which participants self reported their feeling of isolation on a Likert Scale
|
Baseline, 4 weeks (program end), 6 month follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Claire M Mulry, Kean University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mulry, C. M. & Piersol, C. V. (2014). The Let's Go program for community participation: A feasibility study. Physical & Occupational Therapy in Geriatrics, 32(3). doi:10.3109/02703181.2014.932316
- Mulry CM, Papetti C, De Martinis J, Ravinsky M. Facilitating Wellness in Urban-Dwelling, Low-Income Older Adults Through Community Mobility: A Mixed-Methods Study. Am J Occup Ther. 2017 Jul/Aug;71(4):7104190030p1-7104190030p7. doi: 10.5014/ajot.2017.025494.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (ACTUAL)
February 1, 2016
Study Completion (ACTUAL)
February 1, 2016
Study Registration Dates
First Submitted
September 22, 2016
First Submitted That Met QC Criteria
September 23, 2016
First Posted (ESTIMATE)
September 27, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
September 27, 2016
Last Update Submitted That Met QC Criteria
September 23, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Kean-1001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data files will be uploaded for review
Study Data/Documents
-
Individual Participant Data Set
Information comments: Please contact cmulry@kean.edu to request the data set
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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