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

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.

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.
Observational

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.
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

  • United States
    • 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

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

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

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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alpena Senior Citizens Center

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)

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.
February 1, 2021

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.
December 4, 2021

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.
December 4, 2021

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).
December 4, 2020

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.
December 4, 2020

First Posted (ACTUAL)

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.
December 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

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.
January 6, 2022

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.
January 5, 2022

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.
January 1, 2022

More Information

Terms related to this study

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.
  • 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.

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