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Completed

NCT Number: NCT04423666

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.

Completed

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walking using a wireless pedometer

Behavioral

See arm/group

Primary outcomes

  1. Blood pressure

    Time frame: 8 weeks

    systolic/diastolic

  2. Pulse rate will be combined to report BMI in kg/m^2BMI

    Time frame: 8 weeks

    count of pulse rate for one minute

  3. height

    Time frame: 8 weeks

    in meters

  4. weight

    Time frame: 8 weeks

    in kg

  5. BMI

    Time frame: 8 weeks

    weight and height will be combined to report BMI in kg/m^2

Secondary outcomes

  1. wellbeing

    Time frame: 8 weeks

    self report using 7 item Warwick wellbeing where 1 is none to 5 is all of the time (more positive reponse)

  2. Stress level

    Time frame: 8 weeks

    self report using 10-item Perceived Stress Scale where 1 is no stress to 4 is highest level of stress

  3. Qualitative Descriptive

    Time frame: At end of 8 weeks

    interviews

Sponsors and collaborators

Lead sponsor

Boston College

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 9, 2020
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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