Clinical trial NCT05070923: HealthyLifetime: Health Coaching for Older Adults
Official title: Healthy Lifetime (HL): an Internet-based Behavioral Health Coaching Protocol for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging Well
Keywords: nurse coaching
motivational interviewing
aging
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Michigan Department of Health and Human Services
First posted: 2021-10-07
Enrollment: 82
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: 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:

Personal Health System Assessment (PHS Survey) - The foundational piece of HL is strengthening the participant's existing personal health system (PHS) - which we define as the network and interaction of an individual's strengths (such as beliefs, knowledge and skill for self-care and independence), social determinants of health, caregiver supports, and community resources, such as groceries, exercise, transportation, that the participant relies on to sustain health and function. The survey asks questions in the following domains: background information including income; social and spiritual network and support; personal health rating; use of healthcare services (emergency room visits, hospitalizations, primary care visits); lifestyle habits including use of tobacco, alcohol as well as diet, exercise, sleep and sexual behavior; health impact on activities, function, and symptoms; and self-efficacy in performing activities, in symptom management and in medication taking. The PHS Survey is completed by the participant through the web application and takes about 16 minutes to complete based on pilot data obtained in a sample of community living adults 50 years of age and older with one or more chronic conditions.

The PHS Survey results are reviewed by the UMSN Registered Nurse \[either Advanced Practice Registered Nurse (APRN) or BSN- Prepared Registered Nurse (RN)\] prior to the virtual home visit. During the virtual home visit, the nurse reviews the strengths of the PHS Survey, clarifies any information on the Medical History and conducts a home environment assessment completed by the participant under the guidance of the nurse. The nurse describes key results from the PHS Survey particularly focusing on their own words that describe their priority concerns and goals that they had expressed. The purpose of this is to maximize self-awareness and bring into focus the individual's own goals, strengths and areas for improvement forming the framework for beginning the PHS Plan process. The PHS Survey may reveal an individual's PHS network capacity (family, friends, community-organizations, church groups) to meet the person's need for additional in-home support for non-medical services such as housekeeping, bill paying, grocery shopping etc.

Personal Health System Strengthening Plan (PHS Plan) - The next step of the program includes creation of an individualized plan to strengthen capacity of the participant for self-care using the discussion of the PHS Survey and home assessments as a starting point for engaging the participant. The PHS Plan will be developed with the participant in a 45 - 60 minute video session the nurse. The PHS Plan assists the individual to set action steps to meet goals that reflect concerns about managing their medical regimen, medication taking, symptoms, daily living skills such as Activities of Daily Living (ADLs ) and Instrumental Activities of Daily Living (IADLs), and health behavior choices such as smoking, eating habits, activity etc. The nurse uses health coach motivational and nursing interviewing methods to support participant engagement, activation and self-efficacy in skills and decision-making. Goals and action steps progress throughout the 8-week program, with the guidance of the nurse, as the participant achieves success in reaching goals, making more independent choices, and gains self-care efficacy. By the conclusion of the HL program the participant is expected to have experienced the process of goal/action step/success so as to have sustaining capacity to continue the process without requiring the intensive support that HL provides.

Eligibility criteria: Inclusion Criteria:

* 50 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;
* Has not had an ER visit related to his/her chronic conditions in the prior one month (an ER visit related to a one-time, resolved issue such as a bee sting or to have stitches for a household injury will not be cause for exclusion);
* 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.

Exclusion Criteria:

* Are acutely ill or have unstable health problems requiring medical work-up or follow-up clinic visits for monitoring more than every 3 months;
* Have had an ER visit related to his/her chronic condition in the prior one month; (an ER visit related to a one-time, resolved issue such as a bee sting or to have stitches for a household injury will not be cause for exclusion);
* 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).

Primary outcomes:
measure: Change in Participant Self- rated health score
timeFrame: At 0, 8 and 12 weeks after study enrollment.
measure: Change in Self-efficacy in ability to continue essential life activities score
timeFrame: At 0, 8 and 12 weeks after study enrollment.
measure: Change in Independent self care agency score
timeFrame: At 0, 8 and 12 weeks after study enrollment.
measure: Change in Health Habits score
timeFrame: At 0, 8 and 12 weeks after study enrollment.
measure: Change in Goal attainment score
timeFrame: At 0, 8 and 12 weeks after study enrollment.
Secondary outcomes:
measure: Change in Sustained higher values of primary measures at 3 months
timeFrame: 12 weeks after study enrollment
measure: Change in Self-reported medical visits
timeFrame: At 0, 8 and 12 weeks after study enrollment.
Other outcomes:
measure: Change in Perception of health now and in 3 years score
timeFrame: At 0, 8 and 12 week after study enrollments.
measure: Change in Level of Symptomatology score
timeFrame: At 0, 8 and 12 weeks after study enrollment.
measure: Change in Confidence in ability to manage symptoms score
timeFrame: At 0, 8 and 12 weeks after study enrollment.
measure: Change in Level of independence in activities score
timeFrame: At 0, 8 and 12 weeks after study enrollment.
measure: Change in Medication taking self care efficacy score
timeFrame: At 0, 8 and 12 weeks after study enrollment.
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Nursing
state: Michigan
Study officials:
affiliation: University of Michigan
name: Kathleen Potempa, PhD
role: PRINCIPAL_INVESTIGATOR
References: