NCT04423666

Brief Summary

This study aims to:

  1. 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. 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. 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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

1.5 years

First QC Date

May 28, 2020

Last Update Submit

August 5, 2024

Conditions

Keywords

caregiverdementiawellbeingstress

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

EXPERIMENTAL

Will 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

Behavioral: Walking using a wireless pedometer

Control

EXPERIMENTAL

Will receive: 1. education 2. a wireless pedometer with set up

Behavioral: Walking using a wireless pedometer

Interventions

See arm/group

ControlIntervention

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Jane Flanagan, PhD

    Boston College

    PRINCIPAL INVESTIGATOR

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
Model Details: Convenience sample, randomized, intervention, pre-post design
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

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
April 2020 - indefinitely
Access Criteria
notify PI
More information

Locations