Aging WellNCT05920733
Healthy Lifetime - Phase 2
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 older
- 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
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2023to 1 Oct 2026
- 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
- No healthy volunteers
- 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
Official title: Healthy Lifetime - Sustainability and Quality Study - PHASE 2
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 20 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 20 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 20 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 20 weeks after study enrollment.
Change in Goal attainment score
Health goals (up to 3) of participants 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 20 weeks after study enrollment.
Change in Quality of Life score
Questions about how participant experiences their quality of life. Covers six areas and includes how satisfied they are with these areas, and how important they are to them.
Uses a scale where "0" = "Do not agree at all" and "4" = "Agree completely"
Measured: At 0, 8 and 20 weeks after study enrollment.
Change in Lifestyle Habits
Questions about tobacco and alcohol use: Do participants use alcohol and/or tobacco, and, if so, how much
Measured: At 0, 8 and 20 weeks after study enrollment.
Change in Food Consumption
Participants report how frequently they eat foods from different food groups, e.g., vegetables, fruits, grains, dairy, sugary, etc.
Measured: At 0, 8 and 20 weeks after study enrollment.
Change in Exercise and Activities
DURING THE PAST 7 DAYS, even if it was not a typical week for participants, how much total time (for the entire week) did they spend on each of various exercises or activities, e.g., walking, swimming, bicycling, etc.
Measured: At 0, 8 and 20 weeks after study enrollment.
Change in Vigorous Activity
Number of days out of the past seven did participants do vigorous or moderate activities at work, as part of their house and yard work, to get from place to place, and in their spare time for recreation, exercise, or sport.
Measured: At 0, 8 and 20 weeks after study enrollment.
Change in Level of independence in household activities score
Ability to do daily living activities such as shopping, cooking, managing medications, etc. on a scale where 1 = Not at all Confident to 10 = Totally Confident
Measured: At 0, 8 and 20 weeks after study enrollment.
Change in Health Impact
Using a "1" to "10" scale where "1" = "Almost never" and "10" = "Almost totally", participant selects ONE number which best represents how much their health impacts their ability to do or participate in an activity AT THE PRESENT TIME.
Measured: At 0, 8 and 20 weeks after study enrollment.
Change in Confidence in ability to manage symptoms score
How confident the is participant that they can keep health symptoms/problems from interfering with the things they want to do, e.g., fatigue, physical discomfort, emotional distress, etc. on a scale where 1 = Not at all Confident to 10 = Totally Confident
Measured: At 0, 8 and 20 weeks after study enrollment.
Change in Level of Symptomatology score
Frequency with which participants experience symptoms such as physical discomfort, pain, fatigue, etc. on a scale where 0 = Never to 5 = Always
Measured: At 0, 8 and 20 weeks after study enrollment.
Change in Other Symptoms
Questions ask how often a participant is bothered by psychological and emotional symptoms such as feeling nervous, worry, anxiety, sadness, etc. On a scale from 0 Not at All to 3 Nearly Every Day.
Measured: At 0, 8 and 20 weeks after study enrollment.
Secondary outcomes (4)
Higher values of primary measures at 8 weeks: persistence at 20 weeks
Are effects of program noted at 8 weeks still present at 20 weeks.
Measured: 20 weeks after study enrollment
Change in Self-reported medical visits
Number of unplanned medical visits with doctor or primary medical provider in past 2 months (0/none to 10), emergency room visits (0/none to10), overnight stay in hospital (0\none to 10).
Measured: At 0, 8 and 20 weeks after study enrollment.
Change in Social Network and Support score
Number of friends and relatives participants interact with/rely on. Scale from None to Nine or more.
Measured: At 0, 8 and 20 weeks after study enrollment.
Change in type and source of At-home Support
Do the type (healthcare, chores, meals, etc) and source (Medicare, Medicaid, other insurance, etc.) of help received by participants indicated in answers to survey questions change over course of study.
Measured: At 0, 8 and 20 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 posted27 Jun 2023
- Study start5 Jul 2023
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Department of Health and Human Services
- Responsible party
- Principal investigator, Kathleen Potempa, University of Michigan
- Investigators
- Kathleen Potempa, PhD, Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920733
- Sponsor's protocol ID
- HUM00223787
- Status last verified
- Oct 2026
- First submitted
- 18 May 2023
- Last updated
- 21 Oct 2026
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Lifetime - Sustainability and Quality Study - PHASE 2
- ClinicalTrials.gov ID
- NCT05920733
- Acronym / sponsor ID
- HUM00223787
- Conditions
- Aging Well
- Keywords
- nurse coaching, motivational interviewing, aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Michigan Department of Health and Human Services
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 27 Jun 2023 (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
- Not 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 20 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 20 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 20 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 20 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 20 weeks after study enrollment.
Health goals (up to 3) of participants 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)
Change in Quality of Life score
Time frame: At 0, 8 and 20 weeks after study enrollment.
Questions about how participant experiences their quality of life. Covers six areas and includes how satisfied they are with these areas, and how important they are to them. Uses a scale where "0" = "Do not agree at all" and "4" = "Agree completely"
Change in Lifestyle Habits
Time frame: At 0, 8 and 20 weeks after study enrollment.
Questions about tobacco and alcohol use: Do participants use alcohol and/or tobacco, and, if so, how much
Change in Food Consumption
Time frame: At 0, 8 and 20 weeks after study enrollment.
Participants report how frequently they eat foods from different food groups, e.g., vegetables, fruits, grains, dairy, sugary, etc.
Change in Exercise and Activities
Time frame: At 0, 8 and 20 weeks after study enrollment.
DURING THE PAST 7 DAYS, even if it was not a typical week for participants, how much total time (for the entire week) did they spend on each of various exercises or activities, e.g., walking, swimming, bicycling, etc.
Change in Vigorous Activity
Time frame: At 0, 8 and 20 weeks after study enrollment.
Number of days out of the past seven did participants do vigorous or moderate activities at work, as part of their house and yard work, to get from place to place, and in their spare time for recreation, exercise, or sport.
Change in Level of independence in household activities score
Time frame: At 0, 8 and 20 weeks after study enrollment.
Ability to do daily living activities such as shopping, cooking, managing medications, etc. on a scale where 1 = Not at all Confident to 10 = Totally Confident
Change in Health Impact
Time frame: At 0, 8 and 20 weeks after study enrollment.
Using a "1" to "10" scale where "1" = "Almost never" and "10" = "Almost totally", participant selects ONE number which best represents how much their health impacts their ability to do or participate in an activity AT THE PRESENT TIME.
Change in Confidence in ability to manage symptoms score
Time frame: At 0, 8 and 20 weeks after study enrollment.
How confident the is participant that they can keep health symptoms/problems from interfering with the things they want to do, e.g., fatigue, physical discomfort, emotional distress, etc. on a scale where 1 = Not at all Confident to 10 = Totally Confident
Change in Level of Symptomatology score
Time frame: At 0, 8 and 20 weeks after study enrollment.
Frequency with which participants experience symptoms such as physical discomfort, pain, fatigue, etc. on a scale where 0 = Never to 5 = Always
Change in Other Symptoms
Time frame: At 0, 8 and 20 weeks after study enrollment.
Questions ask how often a participant is bothered by psychological and emotional symptoms such as feeling nervous, worry, anxiety, sadness, etc. On a scale from 0 Not at All to 3 Nearly Every Day.
4 secondary outcomes
Higher values of primary measures at 8 weeks: persistence at 20 weeks
Time frame: 20 weeks after study enrollment
Change in Self-reported medical visits
Time frame: At 0, 8 and 20 weeks after study enrollment.
Change in Social Network and Support score
Time frame: At 0, 8 and 20 weeks after study enrollment.
Change in type and source of At-home Support
Time frame: At 0, 8 and 20 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 21 Oct 2026.
- 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 study director
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 21 Oct 2026. 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 20 weeks after study enrollment.). The study lists 15 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 21 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.