Clinical trial NCT02993887: Resourcefulness Training and Decentering on Self-Management in Caregivers of Technology Dependent Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver
Mindfulness
Mechanical Ventilation Pressure High
Gastrostomy
Chronic Illness
Keywords: Caregiver
Technology Dependent Children
Resourcefulness
Mindfulness
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: The Cleveland Clinic
First posted: 2016-12-15
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 outcomes.
5. Explore differences in neurological processing (DMN and TPN) and decentering in proximal and distal outcomes associated with each intervention.

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.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. aged ≥18 years;
3. 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.

Primary outcomes:
measure: Change from Baseline Mental & Physical Health Related Quality of Life at 3 Months & 6 Months
timeFrame: Measured at baseline with follow up at 3 months, 6 months
Secondary outcomes:
measure: Change from Baseline Appraised Sleep Quality at 3 months and 6 months
timeFrame: Measured at baseline with follow up at 3 months, 6 months
measure: Change from Baseline Positive Health Practices at 3 months and 6 months
timeFrame: Measured at baseline with follow up at 3 months, 6 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University, Frances Payne Bolton School of Nursing
name: Valerie A Toly, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.