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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Community dwelling individual
  2. Report desire to learn about community mobility options
  3. Able to participate in group education sessions (
  4. Able to attend during a 45 minute session
  5. Independent mobility in community with or without an assistive device.

Exclusion Criteria:

  1. Individual lives in Long Term Care facility
  2. Aphasia
  3. Individual has impaired cognition demonstrated by MoCA exam score ≤ 17
  4. Individual is unable to stay awake for entire group session
  5. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Let's Go Community Mobility Program
Participation in 4 week program
Other: Let's Go Community Mobility Program
Four week multi-modal education and experiential program to improve community mobilty

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kean University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

  1. 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings