Clinical trial NCT06616246: Training Community Members to be Coaches to Deliver the HealthyLifetime Program
Official title: Evaluating the Use of Community Members Trained as Health Coaches to Deliver the HealthyLifetimeTM Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Behaviors
Functional Decline
Chronic Disease
Risk Factors
Keywords: health coach
health resiliency
independent self-care
community health workers
independent aging
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Michigan Department of Health and Human Services
name: Centers for Medicare and Medicaid Services
First posted: 2024-09-27
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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).

Primary outcomes:
measure: Change in Participant Self- rated satisfaction with various aspects of their home and neighborhood.
timeFrame: At 0, 8 and 20 weeks after study enrollment.
measure: Satisfaction with Quality of Life
timeFrame: At 0, 8 and 20 weeks after study enrollment.
measure: Positive and negative Lifestyle Habits aggregate
timeFrame: At 0, 8 and 20 weeks after study enrollment.
measure: Change in Goal attainment score
timeFrame: At 0, 8 and 12 weeks after study enrollment.
measure: Change in Self-efficacy in ability to continue essential life activities
timeFrame: At 0, 8 and 20 weeks after study enrollment.
Secondary outcomes:
measure: Change in Sustained higher values of primary measures at 3 months
timeFrame: 20 weeks after study enrollment
measure: Change in Self-reported medical visits
timeFrame: At 0, 8 and 20 weeks after study enrollment.
Other outcomes:
measure: CONFIDENCE IN MANAGING SYMPTOMS
timeFrame: At 0, 8 and 20 weeks after study enrollment.
measure: PHYSICAL SYMPTOM INVENTORY
timeFrame: At 0, 8 and 20 weeks after study enrollment.
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Kathleen Potempa, PhD
role: PRINCIPAL_INVESTIGATOR
References: