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Clinical Trials/NCT05920733
NCT05920733
Recruiting
Not Applicable

Healthy Lifetime - Sustainability and Quality Study - PHASE 2

University of Michigan1 site in 1 country120 target enrollmentJuly 5, 2023
ConditionsAging Well

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging Well
Sponsor
University of Michigan
Enrollment
120
Locations
1
Primary Endpoint
Change in Participant Self- rated health score
Status
Recruiting
Last Updated
6 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 5, 2023
End Date
October 1, 2026
Last Updated
6 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kathleen Potempa

Professor

University of Michigan

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Change in Participant Self- rated health score

Time Frame: At 0, 8 and 20 weeks after study enrollment.

Participants perception of their health on a scale of 1= Excellent to 5 = Poor

Change in Food Consumption

Time Frame: At 0, 8 and 20 weeks after study enrollment.

Participants report how frequently they eat foods from different food groups, e.g., vegetables, fruits, grains, dairy, sugary, etc.

Change in Vigorous Activity

Time Frame: At 0, 8 and 20 weeks after study enrollment.

Number of days out of the past seven did participants do vigorous or moderate activities at work, as part of their house and yard work, to get from place to place, and in their spare time for recreation, exercise, or sport.

Change in Independent self-care agency score

Time Frame: At 0, 8 and 20 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

Change in Goal attainment score

Time Frame: At 0, 8 and 20 weeks after study enrollment.

Health goals (up to 3) of participants 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)

Change in Level of Symptomatology score

Time Frame: At 0, 8 and 20 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

Change in Health Habits score

Time Frame: At 0, 8 and 20 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)

Change in Quality of Life score

Time Frame: At 0, 8 and 20 weeks after study enrollment.

Questions about how participant experiences their quality of life. Covers six areas and includes how satisfied they are with these areas, and how important they are to them. Uses a scale where "0" = "Do not agree at all" and "4" = "Agree completely"

Change in Exercise and Activities

Time Frame: At 0, 8 and 20 weeks after study enrollment.

DURING THE PAST 7 DAYS, even if it was not a typical week for participants, how much total time (for the entire week) did they spend on each of various exercises or activities, e.g., walking, swimming, bicycling, etc.

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

Time Frame: At 0, 8 and 20 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.

Change in Lifestyle Habits

Time Frame: At 0, 8 and 20 weeks after study enrollment.

Questions about tobacco and alcohol use: Do participants use alcohol and/or tobacco, and, if so, how much

Change in Level of independence in household activities score

Time Frame: At 0, 8 and 20 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

Change in Confidence in ability to manage symptoms score

Time Frame: At 0, 8 and 20 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

Change in Other Symptoms

Time Frame: At 0, 8 and 20 weeks after study enrollment.

Questions ask how often a participant is bothered by psychological and emotional symptoms such as feeling nervous, worry, anxiety, sadness, etc. On a scale from 0 Not at All to 3 Nearly Every Day.

Change in Health Impact

Time Frame: At 0, 8 and 20 weeks after study enrollment.

Using a "1" to "10" scale where "1" = "Almost never" and "10" = "Almost totally", participant selects ONE number which best represents how much their health impacts their ability to do or participate in an activity AT THE PRESENT TIME.

Secondary Outcomes

  • Change in Self-reported medical visits(At 0, 8 and 20 weeks after study enrollment.)
  • Change in type and source of At-home Support(At 0, 8 and 20 weeks after study enrollment.)
  • Change in Social Network and Support score(At 0, 8 and 20 weeks after study enrollment.)
  • Higher values of primary measures at 8 weeks: persistence at 20 weeks(20 weeks after study enrollment)

Study Sites (1)

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