Healthy Lifetime - Phase 2

October 11, 2025 updated by: Kathleen Potempa, University of Michigan

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

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.

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 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.
Interventional

Enrollment (Estimated)

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.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5482
        • Recruiting
        • University of Michigan School of Nursing
        • Principal Investigator:
          • Kathleen Potempa, PhD
        • Sub-Investigator:
          • Margaret Calarco, PhD
        • Sub-Investigator:
          • Marna Flaherty-Robb, PhD
        • Sub-Investigator:
          • Karen Harden, PhD
        • Contact:
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: HealthyLifetime Group
This project is designed to prepare and equip the participant for improved self-care capacity, motivational insight, health-related problem solving and decision-making.
Behavioral: Nurse-led health coaching
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.
Other Names:
  • HealthyLifetime

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
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
At 0, 8 and 20 weeks after study enrollment.
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.
At 0, 8 and 20 weeks after study enrollment.
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
At 0, 8 and 20 weeks after study enrollment.
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)
At 0, 8 and 20 weeks after study enrollment.
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)
At 0, 8 and 20 weeks after study enrollment.
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"
At 0, 8 and 20 weeks after study enrollment.
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
At 0, 8 and 20 weeks after study enrollment.
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.
At 0, 8 and 20 weeks after study enrollment.
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.
At 0, 8 and 20 weeks after study enrollment.
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.
At 0, 8 and 20 weeks after study enrollment.
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
At 0, 8 and 20 weeks after study enrollment.
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.
At 0, 8 and 20 weeks after study enrollment.
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
At 0, 8 and 20 weeks after study enrollment.
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
At 0, 8 and 20 weeks after study enrollment.
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.
At 0, 8 and 20 weeks after study enrollment.

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
Higher values of primary measures at 8 weeks: persistence at 20 weeks
Time Frame: 20 weeks after study enrollment
Are effects of program noted at 8 weeks still present at 20 weeks.
20 weeks after study enrollment
Change in Self-reported medical visits
Time Frame: At 0, 8 and 20 weeks after study enrollment.
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).
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.
Number of friends and relatives participants interact with/rely on. Scale from None to Nine or more.
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.
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.
At 0, 8 and 20 weeks after study enrollment.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Perception of health now and in 3 years score
Time Frame: At 0, 8 and 20 weeks after study enrollment.
Participant thinks health now is and in three years will be 1 = Excellent to 5 = Poor.
At 0, 8 and 20 weeks after study enrollment.
Change in Medication taking self care efficacy score
Time Frame: At 0, 8 and 20 weeks after study enrollment.
Confidence of participants (on a scale where 0 = Not at all Confident to 2 = very Confident) in taking their medications correctly under different conditions, e.g., if take several medication each day, are away from home, if cause side effects, etc.
At 0, 8 and 20 weeks after study enrollment.
Health Conditions
Time Frame: At 0, 8 and 20 weeks after study enrollment.
Participants are asked whether a medical provider may have told them that they have one or more common health problems, e.g., heart disease, high blood pressure, diabetes, etc.
At 0, 8 and 20 weeks after study enrollment.

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.
Michigan Department of Health and Human Services

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kathleen Potempa, PhD, University of Michigan

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.
July 5, 2023

Primary Completion (Estimated)

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.
October 1, 2026

Study Completion (Estimated)

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.
October 1, 2026

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).
May 18, 2023

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.
June 16, 2023

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.
June 27, 2023

Study Record Updates

Last Update Posted (Estimated)

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.
October 15, 2025

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.
October 11, 2025

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.
October 1, 2025

More Information

Terms related to this study

Keywords

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.
  • HUM00223787

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

product manufactured in and exported from the U.S.

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.

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Locations

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