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Findings of a Health-coached Technology Based Walking Program in Unpaid Caregivers of Persons With Dementia

Findings of a Health-coached Technology Based Walking Program in Unpaid Caregivers of Persons With Dementia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04423666
Enrollment
32
Registered
2020-06-09
Start date
2018-04-01
Completion date
2019-10-01
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

caregiver, dementia, wellbeing, stress

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

Interventions

BEHAVIORALWalking using a wireless pedometer

See arm/group

Sponsors

Boston College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants were randomly assigned through a toss of a coin to either the intervention or control

Intervention model description

Convenience sample, randomized, intervention, pre-post design

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
BMI8 weeksweight and height will be combined to report BMI in kg/m\^2
Pulse rate will be combined to report BMI in kg/m^2BMI8 weekscount of pulse rate for one minute
height8 weeksin meters
weight8 weeksin kg
Blood pressure8 weekssystolic/diastolic

Secondary

MeasureTime frameDescription
Stress level8 weeksself report using 10-item Perceived Stress Scale where 1 is no stress to 4 is highest level of stress
Qualitative DescriptiveAt end of 8 weeksinterviews
wellbeing8 weeksself report using 7 item Warwick wellbeing where 1 is none to 5 is all of the time (more positive reponse)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026