NCT05070923

Brief Summary

To evaluate the benefits of the virtual 8-week program on selected health and functional outcomes, self-efficacy, and resiliency in a population over 50 years of age with one or more chronic conditions versus a randomized control group of like individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 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

Study Start

First participant enrolled

July 20, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 7, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4.1 years

First QC Date

September 23, 2021

Last Update Submit

September 12, 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 12 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 12 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 12 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 12 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 12 weeks after study enrollment.

Secondary Outcomes (2)

  • Change in Sustained higher values of primary measures at 3 months

    12 weeks after study enrollment

  • Change in Self-reported medical visits

    At 0, 8 and 12 weeks after study enrollment.

Other Outcomes (5)

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

    At 0, 8 and 12 week after study enrollments.

  • Change in Level of Symptomatology score

    At 0, 8 and 12 weeks after study enrollment.

  • Change in Confidence in ability to manage symptoms score

    At 0, 8 and 12 weeks after study enrollment.

  • +2 more other outcomes

Study Arms (2)

HealthyLifetime Group

EXPERIMENTAL

HL is an 8-week, personalized health coaching program that includes a comprehensive assessment made through a survey and a "virtual' home visit (via video), a goal-directed strengthening action plan developed by the participant with the guidance of the nurse, a tailored daily planning guide to enhance action steps and goal attainment, and six weekly 30 minute nurse coaching sessions with participants the Healthie application technology via their personal home computer, Tablet or Smartphone device. If a participant does not use a personal device or the device cannot support the Healthie platform, the HL program will provide a Tablet to them for their use during the program. All video sessions ( ie, home visit, strengthening plan, and weekly coaching sessions will use a two-way video but only the audio portions of the sessions will be recorded. The HL program, tailored to each participant's need for strong and resilient function, encompasses the following key elements:

Behavioral: HealthyLifetime

Usual Care Group

NO INTERVENTION

Participants randomized to the usual care group will be given information about when to expect reminders on the Healthie platform to complete future surveys at the end of week 8, and after three months that will be available on the Healthie Platform for them to fill out and save on the platform. They will also be reminded how to contact the study coordinator if they should have questions. Participants in this group will have the view to other functions on the platform turned off. They will only be able to view documents as the reminders appear for them to complete.

Interventions

HealthyLifetimeBEHAVIORAL

HL augments existing case management services by focusing on building the participant's personal capacity for independence in self - care skills, health behavior change, and health decision making. The HL program coordinates and interfaces with the enrollee's primary medical provider, case managers, and caregivers as necessary

HealthyLifetime Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older who have one or more chronic medical conditions (e.g., high blood pressure, diabetes, arthritis, obesity, etc.) which require management in some way (regular doctor checks, medication, etc.);
  • Whose health is medically stable; that is, not currently undergoing either significant physical and/or mental health changes and not undergoing any type of non-routine treatments/medical testing or have any surgeries scheduled in the next six months;
  • Is able to read, speak and hear English; may use adaptive devices such as hearing aid and glasses;
  • Is able to recall personal information such as age, DOB, address, phone number, and health history questions without difficulty;
  • Reports having an established internet connection that is regularly used for video content \[such as with Netflix, Amazon Prime, YouTube\]; and
  • Is able to use their internet connection in a private space.

You may not qualify if:

  • Are acutely ill or have unstable health problems requiring medical work-up or follow-up clinic visits for monitoring more than every 3 months;
  • Are terminally ill;
  • Have severe memory problems;
  • Have severe hearing and/or visual deficits that are not functionally adapted with devices such as a hearing aid or eye glasses;
  • Do not have an existing internet connection at the bandwidth needed to support the video platform \[cannot access video streaming content\]; and/or
  • Is able to use internet only in a public space (unable to ensure privacy).

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

Related Publications (1)

  • Potempa K, Calarco M, Flaherty-Robb M, Butterworth S, Marriott D, Potempa S, Laughlin C, Schmidt P, Struble L, Harden K, Ghosh B, Furspan P, Ellis A. A randomized trial of a theory-driven model of health coaching for older adults: short-term and sustained outcomes. BMC Prim Care. 2023 Oct 5;24(1):205. doi: 10.1186/s12875-023-02162-x.

Study Officials

  • Kathleen Potempa, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 7, 2021

Study Start

July 20, 2020

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations