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NCT02993887 · ClinicalTrials.gov registry record · NA
Resourcefulness Training and Decentering on Self-Management in Caregivers of Technology Dependent Children
A NA study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT02993887 is a NA study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 31 participants.
The verdict
NCT02993887, a NA study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study 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 (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
Interventions
- BEHAVIORAL Mindfulness
- BEHAVIORAL Resourcefulness Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2017-02-20 |
| Est. Completion | 2019-03-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02993887
The ClinicalTrials.gov registry entry for NCT02993887 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mindfulness is the first listed.
NCT02993887 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02993887 about?
NCT02993887 is a clinical study titled "Resourcefulness Training and Decentering on Self-Management in Caregivers of Technology Dependent Children". 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 ...
What is the current status of trial NCT02993887?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2017-02-20. Estimated completion is 2019-03-30.
What interventions are being tested in trial NCT02993887?
The interventions under investigation include: Mindfulness (BEHAVIORAL), Resourcefulness Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT02993887?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
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