Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Case Western Reserve University | OTHER |
| The Cleveland Clinic | OTHER |
Not provided
Not provided
Not provided
Not provided
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 & Thinkâ„¢) 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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness | Placebo Comparator | Mindfulness (Decentering) only using the Stop, Breathe, Think Smart Phone application |
|
| Resourcefulness and Mindfulness | Experimental | Resourcefulness Training (a cognitive behavioral intervention that teaches self-help and help-seeking skills) and Mindfulness using the Stop, Think, Breathe app. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resourcefulness Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 at baseline with follow up at 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Appraised Sleep Quality at 3 months and 6 months | Measure using Pittsburgh Sleep Quality Index | Measured at baseline with follow up at 3 months, 6 months |
| Change from Baseline Positive Health Practices at 3 months and 6 months |
Not provided
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Valerie A Toly, PhD | Case Western Reserve University, Frances Payne Bolton School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106-5065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32205788 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Mindfulness | Behavioral | The mindfulness intervention will include the use of an app daily via Stop, Think, Breathe. |
|
Measure using Personal Lifestyle Questionnaire
| Measured at baseline with follow up at 3 months, 6 months |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided