HealthyNCT02916758
Promoting Community Mobility for Wellness in Older Adults in Urban Environments
A study testing Let's Go Community Mobility Program in people with Healthy, run by Kean University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Let's Go Community Mobility Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Feb 2016
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Let's Go Community Mobility Program
- Keywords
- older adults, community mobility, wellness, isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Let's Go Community Mobility ProgramOther
Four week multi-modal education and experiential program to improve community mobilty
| Study group | Role | What they receive |
|---|---|---|
| Let's Go Community Mobility Program | Experimental | Participation in 4 week program Receives: Other: Let's Go Community Mobility Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Impact on Participation and Autonomy Questionnaire-Autonomy Outdoors Sub scale
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).
Measured: Baseline, 4 weeks (program end), 6 month follow up
Change in Impact on Participation and Autonomy Questionnaire- Social Life and Relationships Sub scale
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).
Measured: Baseline, 4 weeks (program end), 6 month follow up
Change in Frequency of community trips per month
A Participant Survey was developed by the Primary Investigator in which participants self reported the frequency of community trips in the past 30 days
Measured: Baseline, 4 weeks (program end), 6 month follow up
Change in Confidence in community mobility
A Participant Survey was developed by the Primary Investigator in which participants self reported their confidence in community mobility on a Likert Scale
Measured: Baseline, 4 weeks (program end), 6 month follow up
Change in Self report of feelings of isolation
A Participant Survey was developed by the Primary Investigator in which participants self reported their feeling of isolation on a Likert Scale
Measured: Baseline, 4 weeks (program end), 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startJun 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire M. Mulry, OTD, OTR, CAPS, Kean University
- Investigators
- Claire M Mulry, Principal investigator, Kean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916758
- Sponsor's protocol ID
- Kean-1001
- Status last verified
- Sep 2016
- First submitted
- 22 Sep 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data files will be uploaded for review
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.
PubMed 28661382
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Let's Go: Promoting Community Mobility for Wellness in Older Adults in Urban Environments
- ClinicalTrials.gov ID
- NCT02916758
- Acronym / sponsor ID
- Kean-1001
- Conditions
- Healthy
- Keywords
- older adults, community mobility, wellness, isolation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kean UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 27 Sep 2016 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Let's Go Community Mobility Program | Experimental | Other: Let's Go Community Mobility ProgramParticipation in 4 week program |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Let's Go Community Mobility ProgramFour week multi-modal education and experiential program to improve community mobilty | Other | Let's Go Community Mobility Program |
Primary outcome
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).
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).
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
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
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
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 27 Sep 2016.
- BackgroundMulry, 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
- Derived from this study: PubMed 28661382Mulry 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.
- Individual participant dataSharing planned: Yes. Data files will be uploaded for review
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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.
Claire M Mulry principal investigator
Kean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Let's Go Community Mobility Program in people with Healthy, run by Kean University 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 5 inclusion and 5 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 27 Sep 2016. 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?
Change in Impact on Participation and Autonomy Questionnaire-Autonomy Outdoors Sub scale (time frame: Baseline, 4 weeks (program end), 6 month follow up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02916758, which also lists 2 linked publications.
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 27 Sep 2016.