GeriatricsAlpenaNCT04664166
Alpena Otago Telehealth Program
An observational study of Geriatrics and Exercise, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatrics, Exercise, Telemedicine
- What is being tested?
- Alpena Otago Telehealth Program
- Type of treatment
- Pill or oral medicine
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 4 Dec 2021
- Phase
- Observational
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participants are residents living in the Alpena county and are representative of the demographics in a rural community in Michigan.
Who may be able to join
- 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
Who cannot join
- advanced neurologic condition
- severe visual impairments
- falls due to syncope or dizziness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Geriatrics, Exercise, Telemedicine
- Being tested
- Alpena Otago Telehealth Program
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpena Otago Telehealth ProgramOther
Also called Alpena Empowered Movement Program
A physical therapist will use video visits to evaluate the participants and provide exercise instructions from Week 1 to Week 4. Each participant will use the Blue Marble Health in Motion app from a mobile tablet to complete the exercise guided by an avatar at their own pace after receiving the exercise instructions from the physical therapist. Participants are encouraged to exercise three days a week and 30 minutes each day using the app for 6 months. The exercise protocol based on the evidence-based Otago program includes warm up, strengthening, and balance exercise.
3.5. Research Study Design and Data Analyses:
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate
Number of participants completing the program
Measured: 6 months
Fall Risk Questionnaire (FRQ)
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.
Measured: 6 months
Activities-specific Balance Scale (ABC)
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.
Measured: 6 months
PROMIS Global Health Scale v1.2 (PROMIS)
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.
Measured: 6 months
Exercise adherence
Number of exercise trials completed by each participant
Measured: 6 months
Secondary outcomes (4)
30-Second Chair Stand Test (30CST)
The 30-Second Chair Stand Test (30CST) measures functional lower extremity strength.
Measured: 6 months
Timed Up and Go (TUG)
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.
Measured: 6 months
Canadian Occupational Performance Measure (COPM)
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.
Measured: 6 months
Program acceptance
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Feb 2021
- Primary completion4 Dec 2021
- Study completion4 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeriatricsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Alpena Senior Citizens Center
- Responsible party
- Principal investigator, Min-Hui Huang, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664166
- Sponsor's protocol ID
- 00184786
- Acronym
- Alpena
- Status last verified
- Jan 2022
- First submitted
- 4 Dec 2020
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Alpena Otago Telehealth Program
- ClinicalTrials.gov ID
- NCT04664166
- Acronym / sponsor ID
- Alpena / 00184786
- Conditions
- Geriatrics, Exercise, Telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Alpena Senior Citizens Center
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 4 Dec 2021 (actual)
- Study completion
- 4 Dec 2021 (actual)
- First posted
- 11 Dec 2020 (actual)
- 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 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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participants are residents living in the Alpena county and are representative of the demographics in a rural community in Michigan.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- advanced neurologic condition
- severe visual impairments
- falls due to syncope or dizziness
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 |
|---|---|---|
| Alpena Otago Telehealth ProgramAlso: Alpena Empowered Movement ProgramA physical therapist will use video visits to evaluate the participants and provide exercise instructions from Week 1 to Week 4. Each participant will use the Blue Marble Health in Motion app from a mobile tablet to complete the exercise guided by an avatar at their own pace after receiving the exercise instructions from the physical therapist. Participants are encouraged to exercise three days a week and 30 minutes each day using the app for 6 months. The exercise protocol based on the evidence-based Otago program includes warm up, strengthening, and balance exercise. 3.5. Research Study Design and Data Analyses: | Other | – |
Primary outcome
Retention rate
Time frame: 6 months
Number of participants completing the program
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.
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.
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.
Exercise adherence
Time frame: 6 months
Number of exercise trials completed by each participant
4 secondary outcomes
30-Second Chair Stand Test (30CST)
Time frame: 6 months
Timed Up and Go (TUG)
Time frame: 6 months
Canadian Occupational Performance Measure (COPM)
Time frame: 6 months
Program acceptance
Time frame: 6 months
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 6 Jan 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatrics and Exercise, run by University of Michigan 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 7 inclusion and 3 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 6 Jan 2022. 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?
Retention rate (time frame: 6 months). 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?
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 6 Jan 2022.