Aging WellNCT05071326
Healthy Lifetime - Sustainability and Quality Study
A study testing Nurse-led health coaching in people with Aging Well, run by University of Michigan at 1 site in United States.
Trial summary
HealthyLifetime (HL) is a person-centered program that enables older adults to maximize health and optimize functioning - the necessary requisite to successfully remaining independent in their preferred home setting as long as possible, i.e., to age in place. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging Well
- What is being tested?
- Nurse-led health coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2021to 28 Sep 2024
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be able to read, speak English and hear - but may use glasses or hearing aids, if needed;
- Be able to tell us their age, their date of birth, address, and phone number, as well as write down and explain their health problems;
- Have their own computer or iPad (Tablet) with an Internet connection, a working camera and microphone. and
- Be able to use their computer/tablet to connect to video chat sessions like Zoom in a private space in their home or a private room.
Who cannot join
- People who, in the last month, have used the Emergency Room (ER) or stayed in the hospital.
- Are not verified users of Medicaid Home Help services [we will check with the Michigan Department of Health and Human Service to verify that you receive these services using your name, date of birth, and Medicaid identification number];
- Have a new major health problem that they are seeing a doctor about more than once per month;
- Have been told their illness is not curable;
- Cannot remember their name, date of birth or their health problems;
- Cannot use glasses or a hearing aid to see or hear well enough to read materials on the computer or talk to the nurse easily; and,
- Do not have, or cannot use, a computer, iPad or other device with the Internet at home to use Zoom (e.g., internet streaming).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Nursing
Ann Arbor, Michigan, 48109-5482
About this study
HealthyLifetime (HL) is a person-centered program that enables older adults to maximize health and optimize functioning - the necessary requisite to successfully remaining independent in their preferred home setting as long as possible, i.e., to age in place.
Read the detailed description
HL seeks to intervene early in the aging process when individuals have the best chance for longer term benefits of changing their health behavior, as a means to stave off functional decline, and minimize the onset or exacerbation of chronic conditions. And, for individuals who are experiencing any of the barriers described above, our HL program's Nurse Coaches are prepared and experienced in helping them achieve their highest level of functioning and self-care capacity, while integrating and collaborating with, but not duplicating, their medical services such as primary care, specialty care, and case management or medical social services. While the latter medically oriented services support clinical management, they do not focus on helping older adults maximize health and function by building self-care capacity, long term health behavior change capacity and the functional resilience necessary to sustain or regain independent living.
- Conditions
- Aging Well
- Being tested
- Nurse-led health coaching
- Keywords
- nurse coaching, motivational interviewing, aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led health coachingBehavioural
Also called HealthyLifetime
This project is an 6-month program providing an initial 2-month intensive evaluation and personalized virtual individual health coaching experience that is designed to prepare and equip the participant for improved self-care capacity, motivational insight, health-related problem solving and decision-making. This intensive period will then be followed by monthly 30-minute Nurse Coach assessment and individual coaching 'check-in' virtual visits, continued use of the electronic platform tools and health tracking system, and access to group 'virtual coaching' on tailored topics of interest to the cohort.
| Study group | Role | What they receive |
|---|---|---|
| HealthyLifetime Group | Experimental | This project is designed to prepare and equip the participant for improved self-care capacity, motivational insight, health-related problem solving and decision-making. Receives: Behavioral: Nurse-led health coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Participant Self- rated health score
Participants perception of their health on a scale of 1= Excellent to 5 = Poor
Measured: At 0, 8 and 16 weeks after study enrollment.
Change in Self-efficacy in ability to continue essential life activities score
Confidence of the participant in doing certain activities on a scale of 1= Not at all confident to 10 = Totally Confident. For the purposes of answering these questions, confidence is defined as the belief in the participant's chances of being able to do and/or complete an activity (e.g., hobbies and recreation, social visits, chores, errands, etc.) or task (e.g., hobbies and recreation, social visits, chores, errands, etc.) successfully however the participant defines it.
Measured: At 0, 8 and 16 weeks after study enrollment.
Change in Independent self care agency score
Confidence in doing certain activities, e.g., stick to behavior changes, meet goals, and improve health, on a scale of 1= Not at all confident to 10 = Totally Confident
Measured: At 0, 8 and 16 weeks after study enrollment.
Change in Health Habits score
Activities that participants engage in that affect health in a negative or positive way, e.g., smoking (yes or no), alcohol (number of drinks per week), exercise (0 = none to 4= more than 3 hours/week), food choices (seldom or never to 2 or more times a day)
Measured: At 0, 8 and 16 weeks after study enrollment.
Change in Goal attainment score
Health goals of participants (up to 3) and importance of goal (1= Not at all important now to 10 = highest importance now) and confidence in achieving goal (1= Not confident at all to 10 = Completely Confident)
Measured: At 0, 8 and 16 weeks after study enrollment.
Secondary outcomes (2)
Sustained higher values of primary measures at 3 months
Are effects of program noted at 8 weeks still present at 16 weeks.
Measured: 16 weeks after study enrollment
Change in Self-reported medical visits
Number of unplanned medical visits with doctor or primary medical provider in past 3 months (0 = no visits to 8 = 7 or more), emergency room visits (0 = none to 3 = 2 or more), overnight stay in hospital (0 = none to 3 = 2 or more).
Measured: At 0, 8 and 16 weeks after study enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start8 Oct 2021
- Primary completion30 Aug 2024
- Study completion28 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging WellStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Health Endowment Fund
- Responsible party
- Principal investigator, Kathleen Potempa, University of Michigan
- Investigators
- Kathleen Potempa, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071326
- Sponsor's protocol ID
- HUM00195591
- Status last verified
- Oct 2024
- First submitted
- 23 Sep 2021
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Lifetime - Sustainability and Quality Study
- ClinicalTrials.gov ID
- NCT05071326
- Acronym / sponsor ID
- HUM00195591
- Conditions
- Aging Well
- Keywords
- nurse coaching, motivational interviewing, aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Michigan Health Endowment Fund
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 28 Sep 2024 (actual)
- First posted
- 8 Oct 2021 (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.
HealthyLifetime (HL) is a person-centered program that enables older adults to maximize health and optimize functioning - the necessary requisite to successfully remaining independent in their preferred home setting as long as possible, i.e., to age in place.
Detailed description
HL seeks to intervene early in the aging process when individuals have the best chance for longer term benefits of changing their health behavior, as a means to stave off functional decline, and minimize the onset or exacerbation of chronic conditions. And, for individuals who are experiencing any of the barriers described above, our HL program's Nurse Coaches are prepared and experienced in helping them achieve their highest level of functioning and self-care capacity, while integrating and collaborating with, but not duplicating, their medical services such as primary care, specialty care, and case management or medical social services. While the latter medically oriented services support clinical management, they do not focus on helping older adults maximize health and function by building self-care capacity, long term health behavior change capacity and the functional resilience necessary to sustain or regain independent living.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HealthyLifetime Group | Experimental | Behavioral: Nurse-led health coachingThis project is designed to prepare and equip the participant for improved self-care capacity, motivational insight, health-related problem solving and decision-making. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be able to read, speak English and hear - but may use glasses or hearing aids, if needed;
- Be able to tell us their age, their date of birth, address, and phone number, as well as write down and explain their health problems;
- Have their own computer or iPad (Tablet) with an Internet connection, a working camera and microphone. and
- Be able to use their computer/tablet to connect to video chat sessions like Zoom in a private space in their home or a private room.
Key exclusion criteria (7 listed)
- People who, in the last month, have used the Emergency Room (ER) or stayed in the hospital.
- Are not verified users of Medicaid Home Help services [we will check with the Michigan Department of Health and Human Service to verify that you receive these services using your name, date of birth, and Medicaid identification number];
- Have a new major health problem that they are seeing a doctor about more than once per month;
- Have been told their illness is not curable;
- Cannot remember their name, date of birth or their health problems;
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 |
|---|---|---|
| Nurse-led health coachingAlso: HealthyLifetimeThis project is an 6-month program providing an initial 2-month intensive evaluation and personalized virtual individual health coaching experience that is designed to prepare and equip the participant for improved self-care capacity, motivational insight, health-related problem solving and decision-making. This intensive period will then be followed by monthly 30-minute Nurse Coach assessment and individual coaching 'check-in' virtual visits, continued use of the electronic platform tools and health tracking system, and access to group 'virtual coaching' on tailored topics of interest to the cohort. | Behavioural | HealthyLifetime Group |
Primary outcome
Change in Participant Self- rated health score
Time frame: At 0, 8 and 16 weeks after study enrollment.
Participants perception of their health on a scale of 1= Excellent to 5 = Poor
Change in Self-efficacy in ability to continue essential life activities score
Time frame: At 0, 8 and 16 weeks after study enrollment.
Confidence of the participant in doing certain activities on a scale of 1= Not at all confident to 10 = Totally Confident. For the purposes of answering these questions, confidence is defined as the belief in the participant's chances of being able to do and/or complete an activity (e.g., hobbies and recreation, social visits, chores, errands, etc.) or task (e.g., hobbies and recreation, social visits, chores, errands, etc.) successfully however the participant defines it.
Change in Independent self care agency score
Time frame: At 0, 8 and 16 weeks after study enrollment.
Confidence in doing certain activities, e.g., stick to behavior changes, meet goals, and improve health, on a scale of 1= Not at all confident to 10 = Totally Confident
Change in Health Habits score
Time frame: At 0, 8 and 16 weeks after study enrollment.
Activities that participants engage in that affect health in a negative or positive way, e.g., smoking (yes or no), alcohol (number of drinks per week), exercise (0 = none to 4= more than 3 hours/week), food choices (seldom or never to 2 or more times a day)
Change in Goal attainment score
Time frame: At 0, 8 and 16 weeks after study enrollment.
Health goals of participants (up to 3) and importance of goal (1= Not at all important now to 10 = highest importance now) and confidence in achieving goal (1= Not confident at all to 10 = Completely Confident)
2 secondary outcomes
Sustained higher values of primary measures at 3 months
Time frame: 16 weeks after study enrollment
Change in Self-reported medical visits
Time frame: At 0, 8 and 16 weeks after study enrollment.
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 15 Oct 2024.
- 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.
Kathleen Potempa, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led health coaching in people with Aging Well, 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 4 inclusion and 7 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 15 Oct 2024. 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 Participant Self- rated health score (time frame: At 0, 8 and 16 weeks after study enrollment.). 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 15 Oct 2024.