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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04423666
• Other study ID #: BostonCollege
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: June 2020
• Source: Boston College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• Walking using a wireless pedometer
See arm/group

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	systolic/diastolic	8 weeks
Primary	Pulse rate will be combined to report BMI in kg/m^2BMI	count of pulse rate for one minute	8 weeks
Primary	height	in meters	8 weeks
Primary	weight	in kg	8 weeks
Primary	BMI	weight and height will be combined to report BMI in kg/m^2	8 weeks
Secondary	wellbeing	self report using 7 item Warwick wellbeing where 1 is none to 5 is all of the time (more positive reponse)	8 weeks
Secondary	Stress level	self report using 10-item Perceived Stress Scale where 1 is no stress to 4 is highest level of stress	8 weeks
Secondary	Qualitative Descriptive	interviews	At end of 8 weeks

External Links

•   Geriatric Society of America Conference Proceedings