NCT05071326

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 8, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

2.9 years

First QC Date

September 23, 2021

Last Update Submit

October 9, 2024

Conditions

Keywords

nurse coachingmotivational interviewingaging

Outcome Measures

Primary Outcomes (5)

  • 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 16 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 16 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 16 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 16 weeks after study enrollment.

  • Change in Goal attainment score

    Health goals of participants (up to 3) 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 16 weeks after study enrollment.

Secondary Outcomes (2)

  • Sustained higher values of primary measures at 3 months

    16 weeks after study enrollment

  • Change in Self-reported medical visits

    At 0, 8 and 16 weeks after study enrollment.

Other Outcomes (5)

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

    At 0, 8 and 16 weeks after study enrollment.

  • Change in Level of Symptomatology score

    At 0, 8 and 16 weeks after study enrollment.

  • Change in Confidence in ability to manage symptoms score

    At 0, 8 and 16 weeks after study enrollment.

  • +2 more other outcomes

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

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

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan School of Nursing

Ann Arbor, Michigan, 48109-5482, United States

Location

Study Officials

  • Kathleen Potempa, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

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

September 23, 2021

First Posted

October 8, 2021

Study Start

October 8, 2021

Primary Completion

August 30, 2024

Study Completion

September 28, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations