Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04150055 |
| Other study ID # |
Pro2019001438 |
| Secondary ID |
KL2TR003018 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 5, 2019 |
| Est. completion date |
March 8, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Rutgers, The State University of New Jersey |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
