Training Community Members to be Coaches to Deliver the HealthyLifetime Program

NCT06616246 | Recruiting

• 1 other identifier: 24-PAF04327
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this randomized controlled study is to learn if, in addition to nurses, community members can be trained as health coaches to deliver the HealthyLifetime (HL) program to people without complex chronic health conditions, an intervention that provides a short-term and effective health coaching intervention delivered through a virtual platform to improve health, resiliency, and independent self-care to participants who are without complex chronic conditions. The main question it aims to answer is: • Can Community Health Coaches achieve the same level of competency and outcome as Nurse Health Coaches in participants without complex chronic conditions?

Conditions

Health Behaviors; Functional Decline; Chronic Disease; Risk Factors

Keywords

health coach; health resiliency; independent self-care; community health workers; independent aging

Outcome Measures

Primary Outcomes (5)

• Change in Participant Self- rated satisfaction with various aspects of their home and neighborhood.

  Participants perception of their home and neighborhood on a scale of 1= Extremely Satisfied to 5 = Not at all satisfied

  At 0, 8 and 20 weeks after study enrollment.

• Satisfaction with Quality of Life

  Questions are about how participant experiences their quality of life on a scale where "1" = "Do not agree at all" and "5" = "Agree completely",

  At 0, 8 and 20 weeks after study enrollment.

• Positive and negative Lifestyle Habits aggregate

  Composite score of activities that participants engage in that affect health in a negative (lower score) or positive way (higher score) on a scale of 1 to 5. Smoking (yes or no), alcohol (number of drinks per week, 5= none, 5= more than eight), exercise (1 = none to 5= more than 3 hours/week), food choices (One serving or less a day to 5 or more servings a day of positive, e.g., vegetable, or negative food choice, e.g., sugary food), amount of sleep (1 = less than 4 to 5 = more than 7 hours)

  At 0, 8 and 20 weeks after study enrollment.

• Change in Goal attainment score

  Health goals of participants (up to 3) confidence in achieving goal (1= Not confident at all to 10 = Completely Confident)

  At 0, 8 and 12 weeks after study enrollment.

• Change in Self-efficacy in ability to continue essential life activities

  Ability or confidence of the participant in doing certain activities on a scale of 1= Cannot do this myself/Not confident at all to 5 = Always able to do myself/Completely 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.

Secondary Outcomes (2)

• Change in Sustained higher values of primary measures at 3 months

  20 weeks after study enrollment

• Change in Self-reported medical visits

  At 0, 8 and 20 weeks after study enrollment.

Other Outcomes (2)

• CONFIDENCE IN MANAGING SYMPTOMS

  At 0, 8 and 20 weeks after study enrollment.

• PHYSICAL SYMPTOM INVENTORY

  At 0, 8 and 20 weeks after study enrollment.

Study Arms (2)

Nurse Coach

ACTIVE COMPARATOR

HealthyLifetime program is administered by an experienced nurse coach.

Behavioral: HealthyLifetime

Health worker coach

EXPERIMENTAL

HealthyLifetime program is administered by a community health worker

Behavioral: HealthyLifetime

Interventions

HealthyLifetime BEHAVIORAL

HealthyLifetimeTM \[HL\] seeks to intervene early in the aging process when individuals have the best chance for longer-term benefits of changing their health behavior, staving off functional decline, and minimizing the onset or exacerbation of chronic conditions.

Health worker coach; Nurse Coach

Eligibility Criteria

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

You may qualify if:

• Be at least 30 years of age, with no more than three, uncomplicated chronic conditions and want to learn to take better care of their health.
• Independent Living Index (ILI) greater than 35. ILI is derived by averaging the outcome measures scores.
• A score of less than 4 on items related to anxiety and depressive symptoms
• Have Medicare and/or Medicaid insurance.
• Be able to read, speak, and hear English - but may use glasses or hearing aids, if needed;
• Tell us their age, date of birth, address, and phone number, and explain their health problems;
• Have a computer, iPad (Tablet), or Smartphone with an Internet connection, email address, a working camera, and microphone;
• 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
• Are not currently participating in any other studies involving diet, weight management, exercise and/or coaching at the current time; and
• Reside in Michigan.

You may not qualify if:

• ● Are less than 30 years of age.
• Have more than three, uncomplicated chronic conditions.
• A score of more than 4 on items related to anxiety and depressive symptoms
• Do not have Medicare and/or Medicaid insurance.
• Do not reside in Michigan.
• Have a new acute health problem that requires seeing a doctor more than once a month for acute medical treatment.
• Have been told their illness is not curable.
• Need help remembering their name, date of birth, or 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.
• Are currently participating in any other studies involving diet, weight management, exercise and/or coaching at the current time; and
• Do not have, or cannot use, a computer, iPad, or another 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
• Centers for Medicare and Medicaid Services: collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48104, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Health Behavior; Chronic Disease

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathleen Potempa, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Potempa, PhD

CONTACT

734-615-0085; potempa@umich.edu

Margaret Calarco, PhD

CONTACT

734-615-0085; mcalarco@med.umich.edu

Study Design

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

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 27, 2024
• Study Start: May 15, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)