- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04664166
Alpena Otago Telehealth Program (Alpena)
January 5, 2022 updated by: Min-Hui Huang, University of Michigan
Outcomes of Alpena Otago Telehealth Program
This project is to analyze the outcomes of the Alpena Otago Telehealth Program.
The Alpena Senior Citizens Center is implementing the Otago program, an evidence-based, 6-month, home exercise program using live video chats in combination with an online exercise app, Blue Marble.
We will recruit seniors who are participants of the Alpena Otago Telehealth Program to allow the study team to analyze their outcomes.
The goal of the study is to examine the feasibility and efficacy of a 6-month, home-based, Otago Telehealth program for seniors in Alpena.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
23
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
-
-
Michigan
-
Flint, Michigan, United States, 48502
- University of Michigan-Flint
-
-
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
60 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The participants are residents living in the Alpena county and are representative of the demographics in a rural community in Michigan.
Description
Inclusion Criteria:
- participating in Alpena Otago telehealth program
- age >= 60 years
- ability to use a tablet
- ability to walk at home with or without a cane or walker
- ability to exercise like moving arms or legs while standing
- ability to communicate in English and follow instructions
- ability to provide the consent
Exclusion Criteria:
- advanced neurologic condition
- severe visual impairments
- falls due to syncope or dizziness
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention rate
Time Frame: 6 months
|
Number of participants completing the program
|
6 months
|
|
Fall Risk Questionnaire (FRQ)
Time Frame: 6 months
|
The Fall Risk Questionnaire (FRQ) is a self-reported questionnaire with 12 questions for fall risk factors.
Each question is rated 0 for NO (negative) and 1 for YES (positive) for fall risk factor.
The sum of scores from all questions is the test score.
A FRQ score >=4 indicates increased fall risk.
Higher scores correspond to higher fall risk.
|
6 months
|
|
Activities-specific Balance Scale (ABC)
Time Frame: 6 months
|
The Activities-specific Balance Scale (ABC) is a self-reported questionnaire of balance confidence during daily activities with 16 items.
Each item is rated from 0% (NO confidence) to 100% (Completely confident) on maintaining balance for a daily task.
The average of scores from all items is the test score.
An ABC score <=67% indicates increased fall risk.
Lower scores correspond to high worse balance confidence and higher fall risk.
|
6 months
|
|
PROMIS Global Health Scale v1.2 (PROMIS)
Time Frame: 6 months
|
The PROMIS Global Health Scale v1.2 (PROMIS) is a self-reported questionnaire for health-related quality of life in physical and mental health domains.
|
6 months
|
|
Exercise adherence
Time Frame: 6 months
|
Number of exercise trials completed by each participant
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-Second Chair Stand Test (30CST)
Time Frame: 6 months
|
The 30-Second Chair Stand Test (30CST) measures functional lower extremity strength.
|
6 months
|
|
Timed Up and Go (TUG)
Time Frame: 6 months
|
The Timed Up and Go (TUG) measures the time it takes a person to rise up form a chair, walk 10 feet at a normal pace, turn around and sit back down in the chair with or without a mobility device.
The test measures mobility.
|
6 months
|
|
Canadian Occupational Performance Measure (COPM)
Time Frame: 6 months
|
The Canadian Occupational Performance Measure (COPM) is a questionnaire of difficulty in activities of daily living.
Participants are asked to identify daily activities, work, or leisure activities which they want to do, need to do, or are expected to do on a typical day.
|
6 months
|
|
Program acceptance
Time Frame: 6 months
|
Program acceptance is a semi-structured questionnaire about the participant's satisfaction and acceptance of program.
The participants rate their opinions about the expectation, easy of use, perceived benefits and effectiveness of the exercise program on a scale of 1 to 4 (1 = "Strongly disagree", 2 = "Disagree", 3 = "Agree", 4= "Strongly Agree").
There are two open-questions about the frequency of exercise per week and suggestions for program improvement.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (ACTUAL)
February 1, 2021
Primary Completion (ACTUAL)
December 4, 2021
Study Completion (ACTUAL)
December 4, 2021
Study Registration Dates
First Submitted
December 4, 2020
First Submitted That Met QC Criteria
December 4, 2020
First Posted (ACTUAL)
December 11, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 6, 2022
Last Update Submitted That Met QC Criteria
January 5, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 00184786
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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