Aging WellNCT05070923
HealthyLifetime: Health Coaching for Older Adults
A study testing HealthyLifetime in people with Aging Well, run by University of Michigan at 1 site in United States.
Trial summary
To evaluate the benefits of the virtual 8-week program on selected health and functional outcomes, self-efficacy, and resiliency in a population over 50 years of age with one or more chronic conditions versus a randomized control group of like individuals. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging Well
- What is being tested?
- HealthyLifetime
- Type of treatment
- Pill or oral medicine, 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
- 20 Jul 2020to 30 Aug 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 years of age or older who have one or more chronic medical conditions (e.g., high blood pressure, diabetes, arthritis, obesity, etc.) which require management in some way (regular doctor checks, medication, etc.);
- Whose health is medically stable; that is, not currently undergoing either significant physical and/or mental health changes and not undergoing any type of non-routine treatments/medical testing or have any surgeries scheduled in the next six months;
- Has not had an ER visit related to his/her chronic conditions in the prior one month (an ER visit related to a one-time, resolved issue such as a bee sting or to have stitches for a household injury will not be cause for exclusion);
- Is able to read, speak and hear English; may use adaptive devices such as hearing aid and glasses;
- Is able to recall personal information such as age, DOB, address, phone number, and health history questions without difficulty;
- Reports having an established internet connection that is regularly used for video content [such as with Netflix, Amazon Prime, YouTube]; and
- Is able to use their internet connection in a private space.
Who cannot join
- Are acutely ill or have unstable health problems requiring medical work-up or follow-up clinic visits for monitoring more than every 3 months;
- Have had an ER visit related to his/her chronic condition in the prior one month; (an ER visit related to a one-time, resolved issue such as a bee sting or to have stitches for a household injury will not be cause for exclusion);
- Are terminally ill;
- Have severe memory problems;
- Have severe hearing and/or visual deficits that are not functionally adapted with devices such as a hearing aid or eye glasses;
- Do not have an existing internet connection at the bandwidth needed to support the video platform [cannot access video streaming content]; and/or
- Is able to use internet only in a public space (unable to ensure privacy).
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 (HL): an Internet-based Behavioral Health Coaching Protocol for Older Adults
To evaluate the benefits of the virtual 8-week program on selected health and functional outcomes, self-efficacy, and resiliency in a population over 50 years of age with one or more chronic conditions versus a randomized control group of like individuals.
Read the detailed description
HL is an 8-week, personalized health coaching program that includes a comprehensive assessment made through a survey and a "virtual' home visit (via video), a goal-directed strengthening action plan developed by the participant with the guidance of the nurse, a tailored daily planning guide to enhance action steps and goal attainment, and six weekly 30 minute nurse coaching sessions with participants the Healthie application technology via their personal home computer, Tablet or Smartphone device. If a participant does not use a personal device or the device cannot support the Healthie platform, the HL program will provide a Tablet to them for their use during the program. All video sessions ( ie, home visit, strengthening plan, and weekly coaching sessions will use a two-way video but only the audio portions of the sessions will be recorded. The HL program, tailored to each participant's need for strong and resilient function, encompasses the following key elements:
Personal Health System Assessment (PHS Survey) - The foundational piece of HL is strengthening the participant's existing personal health system (PHS) - which we define as the network and interaction of an individual's strengths (such as beliefs, knowledge and skill for self-care and independence), social determinants of health, caregiver supports, and community resources, such as groceries, exercise, transportation, that the participant relies on to sustain health and function. The survey asks questions in the following domains: background information including income; social and spiritual network and support; personal health rating; use of healthcare services (emergency room visits, hospitalizations, primary care visits); lifestyle habits including use of tobacco, alcohol as well as diet, exercise, sleep and sexual behavior; health impact on activities, function, and symptoms; and self-efficacy in performing activities, in symptom management and in medication taking. The PHS Survey is completed by the participant through the web application and takes about 16 minutes to complete based on pilot data obtained in a sample of community living adults 50 years of age and older with one or more chronic conditions.
The PHS Survey results are reviewed by the UMSN Registered Nurse [either Advanced Practice Registered Nurse (APRN) or BSN- Prepared Registered Nurse (RN)] prior to the virtual home visit. During the virtual home visit, the nurse reviews the strengths of the PHS Survey, clarifies any information on the Medical History and conducts a home environment assessment completed by the participant under the guidance of the nurse. The nurse describes key results from the PHS Survey particularly focusing on their own words that describe their priority concerns and goals that they had expressed. The purpose of this is to maximize self-awareness and bring into focus the individual's own goals, strengths and areas for improvement forming the framework for beginning the PHS Plan process. The PHS Survey may reveal an individual's PHS network capacity (family, friends, community-organizations, church groups) to meet the person's need for additional in-home support for non-medical services such as housekeeping, bill paying, grocery shopping etc.
Personal Health System Strengthening Plan (PHS Plan) - The next step of the program includes creation of an individualized plan to strengthen capacity of the participant for self-care using the discussion of the PHS Survey and home assessments as a starting point for engaging the participant. The PHS Plan will be developed with the participant in a 45 - 60 minute video session the nurse. The PHS Plan assists the individual to set action steps to meet goals that reflect concerns about managing their medical regimen, medication taking, symptoms, daily living skills such as Activities of Daily Living (ADLs ) and Instrumental Activities of Daily Living (IADLs), and health behavior choices such as smoking, eating habits, activity etc. The nurse uses health coach motivational and nursing interviewing methods to support participant engagement, activation and self-efficacy in skills and decision-making. Goals and action steps progress throughout the 8-week program, with the guidance of the nurse, as the participant achieves success in reaching goals, making more independent choices, and gains self-care efficacy. By the conclusion of the HL program the participant is expected to have experienced the process of goal/action step/success so as to have sustaining capacity to continue the process without requiring the intensive support that HL provides.
- Conditions
- Aging Well
- Being tested
- HealthyLifetime
- 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.
HealthyLifetimeBehavioural
HL augments existing case management services by focusing on building the participant's personal capacity for independence in self - care skills, health behavior change, and health decision making. The HL program coordinates and interfaces with the enrollee's primary medical provider, case managers, and caregivers as necessary
| Study group | Role | What they receive |
|---|---|---|
| HealthyLifetime Group | Experimental | HL is an 8-week, personalized health coaching program that includes a comprehensive assessment made through a survey and a "virtual' home visit (via video), a goal-directed strengthening action plan developed by the participant with the guidance of the nurse, a tailored daily planning guide to enhance action steps and goal attainment, and six weekly 30 minute nurse coaching sessions with participants the Healthie application technology via their personal home computer, Tablet or Smartphone device. If a participant does not use a personal device or the device cannot support the Healthie platform, the HL program will provide a Tablet to them for their use during the program. All video sessions ( ie, home visit, strengthening plan, and weekly coaching sessions will use a two-way video but only the audio portions of the sessions will be recorded. The HL program, tailored to each participant's need for strong and resilient function, encompasses the following key elements: Receives: Behavioral: HealthyLifetime |
| Usual Care Group | No intervention | Participants randomized to the usual care group will be given information about when to expect reminders on the Healthie platform to complete future surveys at the end of week 8, and after three months that will be available on the Healthie Platform for them to fill out and save on the platform. They will also be reminded how to contact the study coordinator if they should have questions. Participants in this group will have the view to other functions on the platform turned off. They will only be able to view documents as the reminders appear for them to complete. |
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 12 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 12 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 12 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 12 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 12 weeks after study enrollment.
Secondary outcomes (2)
Change in Sustained higher values of primary measures at 3 months
Are effects of program noted at 8 weeks still present at 12 weeks.
Measured: 12 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 12 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 posted7 Oct 2021
- Study start20 Jul 2020
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- 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, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070923
- Sponsor's protocol ID
- E20213681-001
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Potempa K, Calarco M, Flaherty-Robb M, Butterworth S, Marriott D, Potempa S, Laughlin C, Schmidt P, Struble L, Harden K, Ghosh B, Furspan P, Ellis A. A randomized trial of a theory-driven model of health coaching for older adults: short-term and sustained outcomes. BMC Prim Care. 2023 Oct 5;24(1):205. doi: 10.1186/s12875-023-02162-x.
PubMed 37798658
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Lifetime (HL): an Internet-based Behavioral Health Coaching Protocol for Older Adults
- ClinicalTrials.gov ID
- NCT05070923
- Acronym / sponsor ID
- E20213681-001
- 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
- 20 Jul 2020 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 7 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.
To evaluate the benefits of the virtual 8-week program on selected health and functional outcomes, self-efficacy, and resiliency in a population over 50 years of age with one or more chronic conditions versus a randomized control group of like individuals.
Detailed description
HL is an 8-week, personalized health coaching program that includes a comprehensive assessment made through a survey and a "virtual' home visit (via video), a goal-directed strengthening action plan developed by the participant with the guidance of the nurse, a tailored daily planning guide to enhance action steps and goal attainment, and six weekly 30 minute nurse coaching sessions with participants the Healthie application technology via their personal home computer, Tablet or Smartphone device. If a participant does not use a personal device or the device cannot support the Healthie platform, the HL program will provide a Tablet to them for their use during the program. All video sessions ( ie, home visit, strengthening plan, and weekly coaching sessions will use a two-way video but only the audio portions of the sessions will be recorded. The HL program, tailored to each participant's need for strong and resilient function, encompasses the following key elements:
Personal Health System Assessment (PHS Survey) - The foundational piece of HL is strengthening the participant's existing personal health system (PHS) - which we define as the network and interaction of an individual's strengths (such as beliefs, knowledge and skill for self-care and independence), social determinants of health, caregiver supports, and community resources, such as groceries, exercise, transportation, that the participant relies on to sustain health and function. The survey asks questions in the following domains: background information including income; social and spiritual network and support; personal health rating; use of healthcare services (emergency room visits, hospitalizations, primary care visits); lifestyle habits including use of tobacco, alcohol as well as diet, exercise, sleep and sexual behavior; health impact on activities, function, and symptoms; and self-efficacy in performing activities, in symptom management and in medication taking. The PHS Survey is completed by the participant through the web application and takes about 16 minutes to complete based on pilot data obtained in a sample of community living adults 50 years of age and older with one or more chronic conditions.
The PHS Survey results are reviewed by the UMSN Registered Nurse [either Advanced Practice Registered Nurse (APRN) or BSN- Prepared Registered Nurse (RN)] prior to the virtual home visit. During the virtual home visit, the nurse reviews the strengths of the PHS Survey, clarifies any information on the Medical History and conducts a home environment assessment completed by the participant under the guidance of the nurse. The nurse describes key results from the PHS Survey particularly focusing on their own words that describe their priority concerns and goals that they had expressed. The purpose of this is to maximize self-awareness and bring into focus the individual's own goals, strengths and areas for improvement forming the framework for beginning the PHS Plan process. The PHS Survey may reveal an individual's PHS network capacity (family, friends, community-organizations, church groups) to meet the person's need for additional in-home support for non-medical services such as housekeeping, bill paying, grocery shopping etc.
Personal Health System Strengthening Plan (PHS Plan) - The next step of the program includes creation of an individualized plan to strengthen capacity of the participant for self-care using the discussion of the PHS Survey and home assessments as a starting point for engaging the participant. The PHS Plan will be developed with the participant in a 45 - 60 minute video session the nurse. The PHS Plan assists the individual to set action steps to meet goals that reflect concerns about managing their medical regimen, medication taking, symptoms, daily living skills such as Activities of Daily Living (ADLs ) and Instrumental Activities of Daily Living (IADLs), and health behavior choices such as smoking, eating habits, activity etc. The nurse uses health coach motivational and nursing interviewing methods to support participant engagement, activation and self-efficacy in skills and decision-making. Goals and action steps progress throughout the 8-week program, with the guidance of the nurse, as the participant achieves success in reaching goals, making more independent choices, and gains self-care efficacy. By the conclusion of the HL program the participant is expected to have experienced the process of goal/action step/success so as to have sustaining capacity to continue the process without requiring the intensive support that HL provides.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HealthyLifetime Group | Experimental | Behavioral: HealthyLifetimeHL is an 8-week, personalized health coaching program that includes a comprehensive assessment made through a survey and a "virtual' home visit (via video), a goal-directed strengthening action plan developed by the participant with the guidance of the nurse, a tailored daily planning guide to enhance action steps and goal attainment, and six weekly 30 minute nurse coaching sessions with participants the Healthie application technology via their personal home computer, Tablet or Smartphone device. If a participant does not use a personal device or the device cannot support the Healthie platform, the HL program will provide a Tablet to them for their use during the program. All video sessions ( ie, home visit, strengthening plan, and weekly coaching sessions will use a two-way video but only the audio portions of the sessions will be recorded. The HL program, tailored to each participant's need for strong and resilient function, encompasses the following key elements: |
| Usual Care Group | No intervention | –Participants randomized to the usual care group will be given information about when to expect reminders on the Healthie platform to complete future surveys at the end of week 8, and after three months that will be available on the Healthie Platform for them to fill out and save on the platform. They will also be reminded how to contact the study coordinator if they should have questions. Participants in this group will have the view to other functions on the platform turned off. They will only be able to view documents as the reminders appear for them to complete. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 50 years of age or older who have one or more chronic medical conditions (e.g., high blood pressure, diabetes, arthritis, obesity, etc.) which require management in some way (regular doctor checks, medication, etc.);
- Whose health is medically stable; that is, not currently undergoing either significant physical and/or mental health changes and not undergoing any type of non-routine treatments/medical testing or have any surgeries scheduled in the next six months;
- Has not had an ER visit related to his/her chronic conditions in the prior one month (an ER visit related to a one-time, resolved issue such as a bee sting or to have stitches for a household injury will not be cause for exclusion);
- Is able to read, speak and hear English; may use adaptive devices such as hearing aid and glasses;
- Is able to recall personal information such as age, DOB, address, phone number, and health history questions without difficulty;
Key exclusion criteria (7 listed)
- Are acutely ill or have unstable health problems requiring medical work-up or follow-up clinic visits for monitoring more than every 3 months;
- Have had an ER visit related to his/her chronic condition in the prior one month; (an ER visit related to a one-time, resolved issue such as a bee sting or to have stitches for a household injury will not be cause for exclusion);
- Are terminally ill;
- Have severe memory problems;
- Have severe hearing and/or visual deficits that are not functionally adapted with devices such as a hearing aid or eye glasses;
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 |
|---|---|---|
| HealthyLifetimeHL augments existing case management services by focusing on building the participant's personal capacity for independence in self - care skills, health behavior change, and health decision making. The HL program coordinates and interfaces with the enrollee's primary medical provider, case managers, and caregivers as necessary | Behavioural | HealthyLifetime Group |
Primary outcome
Change in Participant Self- rated health score
Time frame: At 0, 8 and 12 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 12 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 12 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 12 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 12 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
Change in Sustained higher values of primary measures at 3 months
Time frame: 12 weeks after study enrollment
Change in Self-reported medical visits
Time frame: At 0, 8 and 12 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 19 Sep 2024.
- Derived from this study: PubMed 37798658Potempa K, Calarco M, Flaherty-Robb M, Butterworth S, Marriott D, Potempa S, Laughlin C, Schmidt P, Struble L, Harden K, Ghosh B, Furspan P, Ellis A. A randomized trial of a theory-driven model of health coaching for older adults: short-term and sustained outcomes. BMC Prim Care. 2023 Oct 5;24(1):205. doi: 10.1186/s12875-023-02162-x.
- 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 HealthyLifetime 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 7 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 19 Sep 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 12 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?
On the ClinicalTrials.gov record for NCT05070923, which also lists 1 linked publication.
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 19 Sep 2024.