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mHealth Mindfulness for Dementia Caregivers

Primary Purpose

Caregiver Burnout, Stress, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Coach
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Caregiver Burnout focused on measuring mindfulness, caregiver, palliative care

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • RWJ Barnabas Monmouth South
  • RWJ Barnabas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Everyone in the study will get Mindfulness Coach and an orientation session. 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 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. We 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.

Outcomes

Primary Outcome Measures

Feasibility - amount of time participants spend in app
how much do caregivers use mindfulness coach
Acceptability - satisfaction with mindfulness coach survey
Do caregivers find mindfulness coach helpful and easy to use?
Bakas Caregiver Outcomes Scale - 15 items
scores range from 15-105 with higher scores indicating better outcomes

Secondary Outcome Measures

hospital anxiety and depression scale- anxiety sub scale
scores range from 0-21 with higher scores indicating worse outcomes
hospital anxiety and depression scale, depression sub scale
scores range from 0-21 with higher scores indicating worse outcomes
The World Health Organization Quality of Life Brief
scores range from 26-130 with higher scores indicating better outcomes
perceived stress scale
scores range from 0-40 with higher scores indicating worse stress

Full Information

First Posted
October 30, 2019
Last Updated
September 3, 2021
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT04150055
Brief Title
mHealth Mindfulness for Dementia Caregivers
Official Title
Piloting an mHealth Mindfulness Therapy Intervention to Alleviate Symptoms of Stress for Caregivers of Older Adults With Cognitive Impairment.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 5, 2019 (Actual)
Primary Completion Date
March 8, 2021 (Actual)
Study Completion Date
March 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burnout, Stress, Anxiety
Keywords
mindfulness, caregiver, palliative care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Everyone in the study will get Mindfulness Coach and an orientation session. 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 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. We 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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Coach
Intervention Description
Mindfulness Coach is an mHealth delivered mindfulness therapy.
Primary Outcome Measure Information:
Title
Feasibility - amount of time participants spend in app
Description
how much do caregivers use mindfulness coach
Time Frame
8 weeks
Title
Acceptability - satisfaction with mindfulness coach survey
Description
Do caregivers find mindfulness coach helpful and easy to use?
Time Frame
8 weeks
Title
Bakas Caregiver Outcomes Scale - 15 items
Description
scores range from 15-105 with higher scores indicating better outcomes
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
hospital anxiety and depression scale- anxiety sub scale
Description
scores range from 0-21 with higher scores indicating worse outcomes
Time Frame
8 weeks
Title
hospital anxiety and depression scale, depression sub scale
Description
scores range from 0-21 with higher scores indicating worse outcomes
Time Frame
8 weeks
Title
The World Health Organization Quality of Life Brief
Description
scores range from 26-130 with higher scores indicating better outcomes
Time Frame
8 weeks
Title
perceived stress scale
Description
scores range from 0-40 with higher scores indicating worse stress
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
RWJ Barnabas Monmouth South
City
Lakewood
State/Province
New Jersey
ZIP/Postal Code
08701
Country
United States
Facility Name
RWJ Barnabas
City
Monroe
State/Province
New Jersey
ZIP/Postal Code
08331
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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mHealth Mindfulness for Dementia Caregivers

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