Clinical trial NCT04423666: Findings of a Health-coached Technology Based Walking Program in Unpaid Caregivers of Persons With Dementia
Official title: Findings of a Health-coached Technology Based Walking Program in Unpaid Caregivers of Persons With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: caregiver
dementia
wellbeing
stress
Lead sponsor: Boston College
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Convenience sample, randomized, intervention, pre-post design
Primary purpose: TREATMENT

Brief summary: This study aims to:

1. Establish the feasibility of a health-coached (HC) walking program utilizing motivational interviewing (MI) and wireless pedometers in family caregivers of persons with dementia.
2. Examine preliminary outcomes of a HC walking program utilizing MI with wireless pedometers on family caregiver's perception of wellbeing, stress, and activity level.
3. Explore caregivers' acceptability and experience of participating in a HC walking program utilizing MI with wireless pedometers and to explore additional person centered approaches.

Detailed description: This comparative study will use a two group repeated measure design and mixed methods approach including well-validated questionnaires and qualitative descriptive methodology. Qualitative inquiry will provide data about the overall experience of caregivers in the intervention arm as well as inform web-based, person centered approaches as suggested by caregivers that will be used to inform future work on person-centered self-care strategies, aimed at improving caregiver health. Eligibility Criteria: having approval from the primary care provider to initiate a walking program, being a caregiver of a person with dementia, being greater than 18 years of age and having access to a computer or smartphone. "The "RSVP \[research volunteer program\] for Health," a registry comprised of individuals interested in receiving information on research studies conducted at Massachusetts General Hospital (MGH), will be utilized for recruitment. If a person states they are interested, they will be called to set up a screening visit to determine study eligibility at which time they will be given the IRB consent to review and a baseline visit will be set up.

At the baseline visit, the consent will be reviewed by the Principal Investigator (PI) and signed by participants meeting eligibility criteria. A member of the study team will obtain demographic and caregiver health characteristics and complete study questionnaires. After baseline measures are obtained, the study team will: 1) provide all participants with education about the CDC physical activity recommendations for adults, 2) set participants up with a wireless pedometer and 3) invite them to join a walking group on-line where they can monitor their activity as compared to others in the intervention arm. Members of the study team will then provide participants in the intervention arm with health coaching (HC) utilizing motivational interviewing (MI) weekly for 8 weeks by email, text message or telephone. The mode of delivery for the MI will be based on participant preference. The control group will be able to view the web page and monitor their activity compared to others in the control group arm, but will receive no coaching." At the end of the 8 weeks, study measures will be again be obtained in both groups. The PI will conduct semi-structured qualitative interviews with participants in the intervention arm to evaluate acceptability and acquire feedback on the intervention and ideas for other self-care strategies." Caregiver Measures Pre - Post

1. Demographic variables
2. General health characteristics
3. Well-being
4. Perceived stress
5. Mini-cog
6. Perceived Steps And post, a qualitative interview

Eligibility criteria: Inclusion Criteria - must have/be:

Approval from the primary care provider to initiate a walking program A caregiver of a person with dementia Greater than age 18 Access access to a computer or smartphone.

Exclusion Criteria:

Not being able to commit to an 8 week walking program

Primary outcomes:
measure: Blood pressure
timeFrame: 8 weeks
measure: Pulse rate will be combined to report BMI in kg/m^2BMI
timeFrame: 8 weeks
measure: height
timeFrame: 8 weeks
measure: weight
timeFrame: 8 weeks
measure: BMI
timeFrame: 8 weeks
Secondary outcomes:
measure: wellbeing
timeFrame: 8 weeks
measure: Stress level
timeFrame: 8 weeks
measure: Qualitative Descriptive
timeFrame: At end of 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Boston College
name: Jane Flanagan, PhD
role: PRINCIPAL_INVESTIGATOR
References: