Findings of a Health-coached Technology Based Walking Program in Unpaid Caregivers of Persons With Dementia
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 28, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedAugust 6, 2024
August 1, 2024
1.5 years
May 28, 2020
August 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (3)
wellbeing
8 weeks
Stress level
8 weeks
Qualitative Descriptive
At end of 8 weeks
Study Arms (2)
Intervention
EXPERIMENTALWill receive: 1. education 2. a wireless pedometer with set up 3. nurse coaching via text message, email or telephone based on participant preference and at frequency determined by the participant
Control
EXPERIMENTALWill receive: 1. education 2. a wireless pedometer with set up
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Not being able to commit to an 8 week walking program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Collegelead
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jane Flanagan, PhD
Boston College
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants were randomly assigned through a toss of a coin to either the intervention or control
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2020
First Posted
June 9, 2020
Study Start
April 1, 2018
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
August 6, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- April 2020 - indefinitely
- Access Criteria
- notify PI
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.