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

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.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Walking using a wireless pedometer

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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Will receive: education; a wireless pedometer with set up; nurse coaching via text message, email or telephone based on participant preference and at frequency determined by the participant	Behavioral: Walking using a wireless pedometer; See arm/group
EXPERIMENTAL: Control; Will receive: education; a wireless pedometer with set up	Behavioral: Walking using a wireless pedometer; See arm/group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	systolic/diastolic	8 weeks
Pulse rate will be combined to report BMI in kg/m^2BMI	count of pulse rate for one minute	8 weeks
height	in meters	8 weeks
weight	in kg	8 weeks
BMI	weight and height will be combined to report BMI in kg/m^2	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wellbeing	self report using 7 item Warwick wellbeing where 1 is none to 5 is all of the time (more positive reponse)	8 weeks
Stress level	self report using 10-item Perceived Stress Scale where 1 is no stress to 4 is highest level of stress	8 weeks
Qualitative Descriptive	interviews	At end of 8 weeks

Collaborators and Investigators

• Sponsor: Boston College
• Investigators: Principal Investigator: Jane Flanagan, PhD, Boston College

Publications and helpful links

Helpful Links

• Geriatric Society of America Conference Proceedings

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ACTUAL): October 1, 2019
• Study Completion (ACTUAL): October 1, 2019

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (ACTUAL): June 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: dementia; stress; caregiver; wellbeing
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: BostonCollege

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Pi will make available upon request the study protocol, SAP, ICF and CSR and as possible these will be shared via dissemination of the findings.
• IPD Sharing Time Frame: April 2020 - indefinitely
• IPD Sharing Access Criteria: notify PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No