Training Community Members to be Coaches to Deliver the HealthyLifetime Program

NCT ID: NCT06616246

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2028-12-31

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?

Detailed Description

The investigators will evaluate the use of trained community members [Health Coach, (HC)] in delivering the HealthyLifetime program to adults without complex chronic conditions. Our cumulative learnings about effective HL strategies, training, and outcomes assessments set the stage for the proposed use of trained community members as HL Health Coaches under the supervision of the nurse Clinical Services Manager. The Independent Living Index (ILI) measures 'risk' for loss of independence due to functional decline from complex chronic conditions and other factors. The investigators will use the ILI and other medical information to determine which participants can be appropriately delegated to non-clinical staff coaches, which the investigators define as participants without complex chronic conditions. Our training methods will be adapted for use with community members. Our health coaching competency assessment tools will be used to measure community members trained as Health Coaches and Nurse Health Coach' relative competency. The investigators will compare quantitative and qualitative outcomes between participants coached by HL Health Coaches (community members) vs. HL Nurse Health Coaches and any outcome differences due to demographic, social determinants, or other factors. Finally, the investigators intend to evaluate the program satisfaction and potential cost impact using our Medical Use Index as a proxy for cost savings.

Conditions

Health Behaviors; Functional Decline; Chronic Disease; Risk Factors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Nurse Coach

HealthyLifetime program is administered by an experienced nurse coach.

Group Type: ACTIVE_COMPARATOR

HealthyLifetime

Intervention Type: 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

HealthyLifetime program is administered by a community health worker

Group Type: EXPERIMENTAL

HealthyLifetime

Intervention Type: 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.

Interventions

HealthyLifetime

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• ● 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).

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michigan Department of Health and Human Services

OTHER

Sponsor Role: collaborator

Centers for Medicare and Medicaid Services

FED

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Potempa

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen Potempa, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

University of Michigan

Ann Arbor, Michigan, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Kathleen Potempa, PhD

Role: CONTACT

potempa@umich.edu

734-615-0085

Margaret Calarco, PhD

Role: CONTACT

mcalarco@med.umich.edu

734-615-0085

Facility Contacts

Margaret Calarco, PhD

Role: primary

mcalarco@med.umich.edu

734-615-0085

Kathleen Potempa, PhD

Role: backup

potempa@umich.edu

734-615-0085

Other Identifiers

24-PAF04327

Identifier Type: -

Identifier Source: org_study_id