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Caregiver BurnoutNCT04150055

mHealth Mindfulness for Dementia Caregivers

A study testing Mindfulness Coach in people with Caregiver Burnout and Stress, run by Rutgers, The State University of New Jersey at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Caregiver Burnout, Stress, Anxiety
What is being tested?
Mindfulness Coach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
5 Nov 2019to 8 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • RWJ Barnabas Monmouth South

    Lakewood, New Jersey, 08701

  • RWJ Barnabas

    Monroe, New Jersey, 08331

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Mindfulness Coach
Keywords
mindfulness, caregiver, palliative care
Medical subject headings
Caregiver Burden, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness CoachBehavioural

    Mindfulness Coach is an mHealth delivered mindfulness therapy.

Study groups in NCT04150055
Study groupRoleWhat they receive
InterventionExperimentalEveryone 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.
Receives: Behavioral: Mindfulness Coach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility - amount of time participants spend in app

    how much do caregivers use mindfulness coach

    Measured: 8 weeks

  2. Acceptability - satisfaction with mindfulness coach survey

    Do caregivers find mindfulness coach helpful and easy to use?

    Measured: 8 weeks

  3. Bakas Caregiver Outcomes Scale - 15 items

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

    Measured: 8 weeks

Secondary outcomes (4)
  1. hospital anxiety and depression scale- anxiety sub scale

    scores range from 0-21 with higher scores indicating worse outcomes

    Measured: 8 weeks

  2. hospital anxiety and depression scale, depression sub scale

    scores range from 0-21 with higher scores indicating worse outcomes

    Measured: 8 weeks

  3. The World Health Organization Quality of Life Brief

    scores range from 26-130 with higher scores indicating better outcomes

    Measured: 8 weeks

  4. perceived stress scale

    scores range from 0-40 with higher scores indicating worse stress

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2019
  2. Study start5 Nov 2019
  3. Primary completion8 Mar 2021
  4. Study completion8 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04150055
Sponsor's protocol ID
Pro2019001438
Other IDs
KL2TR003018
Status last verified
Sep 2021
First submitted
30 Oct 2019
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Coach in people with Caregiver Burnout and Stress, run by Rutgers, The State University of New Jersey at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - amount of time participants spend in app (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.

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