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CaregiverNCT02993887

Resourcefulness Training and Decentering on Self-Management in Caregivers of Technology Dependent Children

A study testing Resourcefulness Training and Mindfulness in people with Caregiver and Mindfulness, run by University Hospitals Cleveland Medical Center at 1 site 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 conduct a randomized clinical trial pilot study to examine the effectiveness of a theoretically based intervention (called ReMind) encompassing two key components: (a) Resourcefulness Training for parent caregivers, and (b) daily mindfulness meditation delivered using a smart phone application… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Resourcefulness Training and Mindfulness
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
1 siteUnited States
Study dates
20 Feb 2017to 30 Mar 2019
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • parent (biological, adoptive, or foster mother, father, grandmother, or grandfather) caregiver for a child aged ≤17 years dependent on medical technology (mechanical ventilators, intravenous nutrition/medication, respiratory or nutritional support) at home;
  • aged ≥18 years;
  • able to speak and understand English.

Who cannot join

  • 1. currently practicing mindfulness-based interventions (yoga, meditation, deep breathing)
  • 2 history of a medical condition or procedure that is contraindicated for imaging (i.e. cardiac pacemaker, sternal wires, or metal implants);
  • 3 claustrophobia requiring anxiolytics or sedation
  • 4 Pregnancy at time of recruitment.
  • 5 If participant becomes pregnant during the follow up period the participant will be excluded from all imaging studies.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106-5065

Other trials in United States

About this study

Official title: The Effects of Resourcefulness Training Intervention and Decentering on Self-Management of Stress in Caregivers of Children With Complex Chronic Conditions Dependent on Lifesaving Medical Technology: A Pilot Study

The investigators will conduct a randomized clinical trial pilot study to examine the effectiveness of a theoretically based intervention (called ReMind) encompassing two key components: (a) Resourcefulness Training for parent caregivers, and (b) daily mindfulness meditation delivered using a smart phone application (Stop, Breathe \& Think™) with an intervention (Mind Only) that consists only of daily mindfulness meditation. Both components of the intervention have been tested separately (but not combined) and both interventions can be self-tailored, which meets the vital need for these caregivers to engage in self-management activities when it is convenient for them. The investigators will test the two arms of the intervention in 30 parents of technology-dependent children, 15 parents in each group. The investigators will collect mixed data at baseline, 3 months and 6 months after subject enrollment to describe changes in proximal and distal outcomes. The investigators aim to:

  1. Evaluate the intermediate (3 month) and long-term (6 month) effects of the ReMind and Mind Only interventions on study mediators (HPA Axis Function and stress, cognitive factors, resourcefulness) and determine if there are different effects between ReMind and Mind Only interventions.
  2. Evaluate the differences in distal psychological (Mental Health Related Quality of Life, Depressive Cognitions, Depressive Symptoms, Anxiety, Caregiver Burden), physical (Physical Health Related Quality of Life), and cost outcomes between subjects in the ReMind and Mind Only arms over time.
  3. Determine the moderating effects of parents' social support, demographics (age, gender, family income) and children's functional status on (a) proximal outcomes and the relationship between (a) the intervention arm and distal outcomes, and (b) HPA Axis Function, stress, cognitive factors and distal outcomes.
  4. Evaluate the impact of decentering on the association between the interventions and the proximal and distal outcomes.
  5. Explore differences in neurological processing (DMN and TPN) and decentering in proximal and distal outcomes associated with each intervention.
Read the detailed description

Design Overview. The investigators will conduct a two-arm Randomized Clinical Trial to compare the effects of the ReMind with the Mind interventions on psychological and physical health outcomes and cognitive task switching between the DMN and TPN neural networks in Functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI). The full ReMind intervention involves daily self-tailored mindful meditation application focused on kindness and compassion for 4 weeks with self-selected frequency of use thereafter. The application that is being used is theoretically constructed and tested and can be delivered on a smart phone app for free (iPad, computer as well). ReMind also includes five resourcefulness training aspects: 1) one face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills, 2) ongoing web access to video vignettes of parents of technology-dependent children describing the application of resourcefulness skills in daily life, 3) 4 weeks of skills' reinforcement using daily journal writing by the parents, 4) weekly phone calls from the intervention nurse over 4 weeks after face-to-face intervention training. The Mind Only intervention includes only the meditation component. Thus, the investigators will be able to see if the addition of Resourcefulness Training will significantly impact proximal outcomes (self management behaviors) such as appraised sleep quality, positive health practices and distal outcomes such as psychological health (Mental Health Related Quality of Life, depressive cognitions, anxiety, caregiver burden), physical health (Physical Health Related Quality of Life), and economic costs.

Sample. A purposive sample of 30 parent caregivers of technology-dependent children (n=15 ReMind, n=15 Mind Only) seen at outpatient clinics (Pulmonology, Gastroenterology, Trach/Vent). The investigators have used this patient population in prior work. Given the availability of potential subjects and the investigator's experience with this population, the investigators anticipate little difficulty in recruiting 30 subjects.

Being tested
Resourcefulness Training, Mindfulness
Keywords
Caregiver, Technology Dependent Children, Resourcefulness, Mindfulness
Medical subject headings
Chronic Disease

What participants receive

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

  • Resourcefulness TrainingBehavioural

    This intervention will include a one time face to face instruction on Resourcefulness Training that entails 8 self-help and help-seeking skills plus viewing short video vignettes of caregivers describing application of the resourcefulness skills. In addition, participants will use daily journaling to describe application of the resourcefulness skills in their daily caregiving with their technology-dependent child.

  • MindfulnessBehavioural

    The mindfulness intervention will include the use of an app daily via Stop, Think, Breathe.

Study groups in NCT02993887
Study groupRoleWhat they receive
MindfulnessPlacebo comparatorMindfulness (Decentering) only using the Stop, Breathe, Think Smart Phone application
Receives: Behavioral: Mindfulness
Resourcefulness and MindfulnessExperimentalResourcefulness Training (a cognitive behavioral intervention that teaches self-help and help-seeking skills) and Mindfulness using the Stop, Think, Breathe app.
Receives: Behavioral: Resourcefulness Training; Behavioral: Mindfulness

What is being measured

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

  1. Change from Baseline Mental & Physical Health Related Quality of Life at 3 Months & 6 Months

    Measure using the Patient Reported Outcomes Measurement Information System (PROMIS)-29

    Measured: Measured at baseline with follow up at 3 months, 6 months

Secondary outcomes (2)

  1. Change from Baseline Appraised Sleep Quality at 3 months and 6 months

    Measure using Pittsburgh Sleep Quality Index

    Measured: Measured at baseline with follow up at 3 months, 6 months

  2. Change from Baseline Positive Health Practices at 3 months and 6 months

    Measure using Personal Lifestyle Questionnaire

    Measured: Measured at baseline with follow up at 3 months, 6 months

Timeline

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

  1. First posted15 Dec 2016 (estimated)
  2. Study start20 Feb 2017
  3. Primary completion30 Mar 2019
  4. Study completion30 Mar 2019

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02993887
Sponsor's protocol ID
10-16-10
Status last verified
Sep 2019
First submitted
8 Dec 2016
Last updated
25 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Moore SM, Musil CM, Alder ML, Pignatiello G, Higgins P, Webel A, Wright KD. Building a Research Data Repository for Chronic Condition Self-Management Using Harmonized Data. Nurs Res. 2020 Jul/Aug;69(4):254-263. doi: 10.1097/NNR.0000000000000435.

    PubMed 32205788

Questions about this trial

What is this clinical trial studying?

A study testing Resourcefulness Training and Mindfulness in people with Caregiver and Mindfulness, run by University Hospitals Cleveland Medical Center at 1 site 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 5 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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?

Change from Baseline Mental & Physical Health Related Quality of Life at 3 Months & 6 Months (time frame: Measured at baseline with follow up at 3 months, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02993887, which also lists 1 linked publication.

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 25 Sep 2019.

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