Findings of a Health-coached Technology Based Walking Program in Unpaid Caregivers of Persons With Dementia
Primary Purpose
Dementia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Walking using a wireless pedometer
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring caregiver, dementia, wellbeing, stress
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intervention
Control
Arm Description
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
Will receive: education a wireless pedometer with set up
Outcomes
Primary Outcome Measures
Blood pressure
systolic/diastolic
Pulse rate will be combined to report BMI in kg/m^2BMI
count of pulse rate for one minute
height
in meters
weight
in kg
BMI
weight and height will be combined to report BMI in kg/m^2
Secondary Outcome Measures
wellbeing
self report using 7 item Warwick wellbeing where 1 is none to 5 is all of the time (more positive reponse)
Stress level
self report using 10-item Perceived Stress Scale where 1 is no stress to 4 is highest level of stress
Qualitative Descriptive
interviews
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04423666
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to:
Establish the feasibility of a health-coached (HC) walking program utilizing motivational interviewing (MI) and wireless pedometers in family caregivers of persons with dementia.
Examine preliminary outcomes of a HC walking program utilizing MI with wireless pedometers on family caregiver's perception of wellbeing, stress, and activity level.
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
Demographic variables
General health characteristics
Well-being
Perceived stress
Mini-cog
Perceived Steps And post, a qualitative interview
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
caregiver, dementia, wellbeing, stress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Convenience sample, randomized, intervention, pre-post design
Masking
Participant
Masking Description
Participants were randomly assigned through a toss of a coin to either the intervention or control
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Experimental
Arm Description
Will receive:
education
a wireless pedometer with set up
Intervention Type
Behavioral
Intervention Name(s)
Walking using a wireless pedometer
Intervention Description
See arm/group
Primary Outcome Measure Information:
Title
Blood pressure
Description
systolic/diastolic
Time Frame
8 weeks
Title
Pulse rate will be combined to report BMI in kg/m^2BMI
Description
count of pulse rate for one minute
Time Frame
8 weeks
Title
height
Description
in meters
Time Frame
8 weeks
Title
weight
Description
in kg
Time Frame
8 weeks
Title
BMI
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
wellbeing
Description
self report using 7 item Warwick wellbeing where 1 is none to 5 is all of the time (more positive reponse)
Time Frame
8 weeks
Title
Stress level
Description
self report using 10-item Perceived Stress Scale where 1 is no stress to 4 is highest level of stress
Time Frame
8 weeks
Title
Qualitative Descriptive
Description
interviews
Time Frame
At end of 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Flanagan, PhD
Organizational Affiliation
Boston College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.bc.edu/bc-web/schools/cson/faculty-research/faculty-directory/jane-m--flanagan.html
Links:
URL
https://academic.oup.com/innovateage/article/3/Supplement_1/S288/5615604
Description
Geriatric Society of America Conference Proceedings
Learn more about this trial
Findings of a Health-coached Technology Based Walking Program in Unpaid Caregivers of Persons With Dementia
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