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Clinical Trials/NCT04150055
NCT04150055
Completed
Not Applicable

Piloting an mHealth Mindfulness Therapy Intervention to Alleviate Symptoms of Stress for Caregivers of Older Adults With Cognitive Impairment.

Rutgers, The State University of New Jersey2 sites in 1 country60 target enrollmentNovember 5, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Caregiver Burnout
Sponsor
Rutgers, The State University of New Jersey
Enrollment
60
Locations
2
Primary Endpoint
Feasibility - amount of time participants spend in app
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The investigators will recruit 60 family caregivers of older adults with cognitive impairment or dementia to participate in a pilot feasibility and acceptability trial of Mindfulness Coach, an mHealth mobile application that delivers mindfulness therapy. Mindfulness Coach is a self-guided mHealth intervention designed to help individuals learn MT, an evidence-based treatment to enhance health, wellness and mental health. The app also offers a library of information about MT (e.g., "how to anchor participants' attention"), 12 audio-guided mindfulness exercises, and a catalog of additional exercises available for free. In addition to collecting data about the feasibility and acceptability of Mindfulness Coach with caregivers of patients with dementia or cognitive impairment, the investigators will also collect data on preliminary efficacy of Mindfulness Coach at relieving symptoms of caregiver burden, anxiety, stress and depression.

Detailed Description

The objective of this project is to evaluate the feasibility, acceptability and preliminary efficacy of Mindfulness Coach for stress and caregiver burden in caregivers of persons with dementia. The investigators will recruit participants across three outpatient geriatric primary care sites in the RWJ Barnabas Healthcare system: Monmouth, Monroe and New Brunswick. Mindfulness Coach is a self-guided mHealth intervention designed to help individuals learn MT, an evidence-based treatment to enhance health, wellness and mental health. The app also offers a library of information about MT (e.g., "how to anchor your attention"), 12 audio-guided mindfulness exercises, and a catalog of additional exercises available for free. The app tracks progress over time with a mindfulness mastery assessment, has customizable reminders which the patient will learn to set during orientation, and goal-setting and tracking features, which the patient will learn to customize during orientation. Mindfulness Coach was designed by a multidisciplinary team of experts in telehealth, technology and mental health from the VA's National Center for PTSD and the Department of Defense's National Center for Telehealth and Technology and is free and available on iOS and Android. In this study, the intervention will be introduced during 1 in-person session by a trained research assistant with 1-2 booster instructional phone call at 7 and 14-days to ensure that the participant knows how and is encouraged to use the app. The participant will also be provided with a laminated card that provides the basic instructions. The investigators will encourage the participant to use Mindfulness Coach weekly for 8 weeks, or more if desired, as this treatment dose is commensurate with most in-person MT psychotherapy treatment protocols. Subjects and Sample Size:The investigators will recruit 60 patients from three RWJ Barnabas sites: Monmouth, Monroe and New Brunswick. Caregivers will be recruited by physician referral. Physicians will identify patients with a diagnosis of dementia or cognitive impairment and their family caregivers. The term "family caregiver" refers to any family member or relative who is involved in a patient's health care because of a personal connection, not for financial compensation. Family caregivers are eligible if they are age 21 or older, English-speaking, currently own a mobile device (smartphone or tablet) and spend at least 10 hours per week providing care to the older adult patient. Procedures: Providers will notify study coordinator of patients who have a diagnosis of dementia or cognitive impairment and typically have a family caregiver present during medical visits. Emails will be sent to providers to inquire about potential subjects. The study research assistant (RA) will call potential subjects to obtain consent for a phone screen. The screen will include questions about current caregiving practices and questions about mobile device usage (e.g., do participants own a smart phone or tablet? How often do participants use this device?). If a patient is eligible and interested in participating, an in-person baseline assessment and orientation will be scheduled at the primary care provider's office. Informed consent will be obtained in person prior to the baseline assessment. The baseline assessor will also be the individual who orients participants to Mindfulness Coach. Follow-up interviews will be conducted via telephone. The orientation will consist of the following components: 1.) education about the app, its developers and MT (to establish credibility); 2.) discussion of goals of the app; 3.) procedural information about how to launch and navigate the app; and 4.) assessment of participant's ability to use the app: participants must be able to meet pre-established criteria of being able to open, launch, navigate and use the app independently prior to the end of the orientation session. During orientation, study personnel will discuss the benefits of daily, brief (5-15 minutes) mindfulness practice and ask participants if daily practice is a goal they would be willing to set. If the participant is amenable, study personnel will help participants set reminders (push notifications) within Mindfulness Coach to facilitate daily practice. The investigators will work with each participant to set mindfulness practice goals that are tailored to the unique needs of each participant. Participants will also be given a laminated instructional card explaining how to access and use Mindfulness Coach. Booster sessions: The study RA will schedule a 1-week booster phone call with intervention participants to troubleshoot potential difficulties users may be experiencing with the application. At this session, participants will be asked if they have used the app in their first week. If they have not, the investigators will schedule an additional follow up booster session phone call at 2-weeks to provide additional troubleshooting and encouragement.

Registry
clinicaltrials.gov
Start Date
November 5, 2019
End Date
March 8, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elissa Kozlov, Ph.D

Core Faculty, Instructor

Rutgers, The State University of New Jersey

Eligibility Criteria

Inclusion Criteria

  • owns a smart phone or tablet
  • speaks English fluently, aged 21+
  • identifies as the caregiver for an older adult with dementia or mild cognitive impairment

Exclusion Criteria

  • does not own smart phone or tablet
  • does not speak English fluently
  • is under age 21
  • does not provide care for older adult with dementia or mild cognitive impairment.

Outcomes

Primary Outcomes

Feasibility - amount of time participants spend in app

Time Frame: 8 weeks

how much do caregivers use mindfulness coach

Acceptability - satisfaction with mindfulness coach survey

Time Frame: 8 weeks

Do caregivers find mindfulness coach helpful and easy to use?

Bakas Caregiver Outcomes Scale - 15 items

Time Frame: 8 weeks

scores range from 15-105 with higher scores indicating better outcomes

Secondary Outcomes

  • The World Health Organization Quality of Life Brief(8 weeks)
  • hospital anxiety and depression scale- anxiety sub scale(8 weeks)
  • perceived stress scale(8 weeks)
  • hospital anxiety and depression scale, depression sub scale(8 weeks)

Study Sites (2)

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