Healthy Lifetime - Sustainability and Quality Study

October 9, 2024 updated by: Kathleen Potempa, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Detailed Description

HL seeks to intervene early in the aging process when individuals have the best chance for longer term benefits of changing their health behavior, as a means to stave off functional decline, and minimize the onset or exacerbation of chronic conditions. And, for individuals who are experiencing any of the barriers described above, our HL program's Nurse Coaches are prepared and experienced in helping them achieve their highest level of functioning and self-care capacity, while integrating and collaborating with, but not duplicating, their medical services such as primary care, specialty care, and case management or medical social services. While the latter medically oriented services support clinical management, they do not focus on helping older adults maximize health and function by building self-care capacity, long term health behavior change capacity and the functional resilience necessary to sustain or regain independent living.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5482
        • University of Michigan School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HealthyLifetime Group
This project is designed to prepare and equip the participant for improved self-care capacity, motivational insight, health-related problem solving and decision-making.
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.
Other Names:
  • HealthyLifetime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Participant Self- rated health score
Time Frame: At 0, 8 and 16 weeks after study enrollment.
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
Time Frame: At 0, 8 and 16 weeks after study enrollment.
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
Time Frame: At 0, 8 and 16 weeks after study enrollment.
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
Time Frame: At 0, 8 and 16 weeks after study enrollment.
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
Time Frame: At 0, 8 and 16 weeks after study enrollment.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained higher values of primary measures at 3 months
Time Frame: 16 weeks after study enrollment
Are effects of program noted at 8 weeks still present at 16 weeks.
16 weeks after study enrollment
Change in Self-reported medical visits
Time Frame: At 0, 8 and 16 weeks after study enrollment.
Number of unplanned medical visits with doctor or primary medical provider in past 3 months (0 = no visits to 8 = 7 or more), emergency room visits (0 = none to 3 = 2 or more), overnight stay in hospital (0 = none to 3 = 2 or more).
At 0, 8 and 16 weeks after study enrollment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Perception of health now and in 3 years score
Time Frame: At 0, 8 and 16 weeks after study enrollment.
Participant thinks health now is and in three years will be 1 = Excellent to 5 = Poor.
At 0, 8 and 16 weeks after study enrollment.
Change in Level of Symptomatology score
Time Frame: At 0, 8 and 16 weeks after study enrollment.
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 16 weeks after study enrollment.
Change in Confidence in ability to manage symptoms score
Time Frame: At 0, 8 and 16 weeks after study enrollment.
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 16 weeks after study enrollment.
Change in Level of independence in activities score
Time Frame: At 0, 8 and 16 weeks after study enrollment.
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 16 weeks after study enrollment.
Change in Medication taking self care efficacy score
Time Frame: At 0, 8 and 16 weeks after study enrollment.
Confidence of participants (on a scale where 0 = Not at all Confident to 2 = very Confident) in taking their medications correctly under different conditions, e.g., if take several medication each day, are away from home, if cause side effects, etc.
At 0, 8 and 16 weeks after study enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kathleen Potempa, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2021

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

September 28, 2024

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 8, 2021

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • HUM00195591

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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