Healthy Lifetime - Phase 2

NCT05920733 | Recruiting

• 1 other identifier: HUM00223787
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging Well

Keywords

nurse coaching; motivational interviewing; aging

Outcome Measures

Primary Outcomes (15)

• Change in Participant Self- rated health score

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (4)

• Higher values of primary measures at 8 weeks: persistence at 20 weeks

  20 weeks after study enrollment

• Change in Self-reported medical visits

  At 0, 8 and 20 weeks after study enrollment.

• Change in Social Network and Support score

  At 0, 8 and 20 weeks after study enrollment.

• Change in type and source of At-home Support

  At 0, 8 and 20 weeks after study enrollment.

Other Outcomes (3)

• Change in Perception of health now and in 3 years score

  At 0, 8 and 20 weeks after study enrollment.

• Change in Medication taking self care efficacy score

  At 0, 8 and 20 weeks after study enrollment.

• Health Conditions

  At 0, 8 and 20 weeks after study enrollment.

Study Arms (1)

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.

Behavioral: Nurse-led health coaching

Interventions

Nurse-led health coaching BEHAVIORAL

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.

Also known as: HealthyLifetime

HealthyLifetime Group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Michigan: lead
• Michigan Department of Health and Human Services: collaborator

Study Sites (1)

University of Michigan School of Nursing

Ann Arbor, Michigan, 48109-5482, United States

RECRUITING

Study Officials

• Kathleen Potempa, PhD

  University of Michigan

  STUDY DIRECTOR

Central Study Contacts

Margaret Calarco, PhD

CONTACT

734-647-3857; mcalarco@umich.edu

Kathleen Potempa, PhD

CONTACT

734-615-0085; potempa@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 27, 2023
• Study Start: July 5, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)