Clinical trial NCT04105244: Self-Management in Parents of Technology-Dependent Children
Official title: Resourcefulness Intervention to Promote Self-Management in Parents of Technology-Dependent Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers
Parents
Self-Management
Chronic Illnesses, Multiple
Keywords: Mental Health
Physical Health
Technology-Dependent Children
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-09-26
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed study is a longitudinal (9-month) randomized controlled trial (RCT) in which primary caregiver parents of technology-dependent children will be randomly assigned to one of two study arms: (1) The Attention Control arm and (2) The Resourcefulness Training(c) arm.
Primary purpose: TREATMENT

Brief summary: Parent caregivers of children with chronic conditions who require life-saving technology such as mechanical ventilation or feeding tubes must maintain a high level of vigilance 24 hours a day, 7 days a week. They usually provide a majority of their children's care and are often overwhelmed by the caregiving demands thus neglect health promotion behaviors that result in a deterioration of their own mental and physical health. The goal of this study is to test a cognitive-behavioral resourcefulness intervention that will improve these caregivers' mental and physical health and health promotion behaviors while they continue to provide vital care for these vulnerable children.

Detailed description: Parent caregivers of children who require life-saving technology such as mechanical ventilation or feeding tubes must maintain a high level of vigilance 24 hours a day, 7 days a week. They report greater levels of stress, compromised self-management behaviors and poorer psychological and physical health than other caregiver groups which dramatically increases their mortality risk. Technology-dependent children (approximately 600,000) are among the sickest and most vulnerable subset of children with complex chronic conditions in the United States. They comprise 20% of all children discharged from the hospital to home, yet account for 61% of healthcare spending for children, up to $110 billion annually. Despite the adverse consequences for caregivers, there are no interventions to meet their specific needs. Resourcefulness Training, (cognitive-behavioral self-management intervention) has been shown to improve psychological and physical outcomes, mediate the effects of stress, and enhance the care provided to care-recipients. A Resourcefulness Training Intervention (RTI) will be tested in a randomized trial against an attention control group. The RTI includes face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills, ongoing web access to the RTI video and video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life, 4 weeks of skills' reinforcement using daily log, weekly phone calls for the first 4 weeks, and booster sessions at 2 and 4 months post enrollment. The Attention Control group will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care. The aims of the study are to: 1) Determine whether the RTI versus Attention Control improves psychological (mental HRQoL depressive cognitions, depressive symptoms, appraised stress, burden) and physical outcomes (physical HRQoL, chronic stress \[hair cortisol\]) over 9 months in parents of technology-dependent children, after controlling for covariates (parent race/ethnicity and gender, family income, and children's functional status, type of technology). 2) Determine whether changes in psychological and physical outcomes are mediated by changes in parents' levels of resourcefulness based on intervention condition. 3) Compare self-management behavior (sleep, positive health practices) over 9 months in parents who received RTI versus Attention Control. 4) Explore whether resourcefulness is a mediator between intervention condition and self-management behaviors controlling for baseline self-management behavior over 9 months. 5) Explore the relationship between self-management behavior and parent psychological and physical outcomes based on intervention condition. Our study will be the first to test a cognitive-behavioral RTI for this caregiver population. 6) Compare target children's ER visits, hospital days over 9 months based on parent intervention condition. If shown to be efficacious, it can be replicated with other caregivers of children with complex chronic conditions with strong potential for translation into practice.

Eligibility criteria: Inclusion Criteria:

* parent primary caregiver (biological, adoptive, or foster mother, father, grandmother, or grandfather) for a technology-dependent child based on the Office of Technology Assessment (OTA) classification criteria (Group 1, mechanical ventilators; Group 2, intravenous nutrition/medication; Group 3, respiratory or nutritional support);
* at least 18 years of age;
* able to speak and understand English;
* the technology-dependent child must be age 17.2 years or younger and receive care in the home from his/her parent. For children with more than one type of technology, we will follow OTA guidelines for classification.

Exclusion Criteria:

- Parents of children with a cancer diagnosis due to the short term use of technology following initial diagnosis and treatment

Primary outcomes:
measure: Psychological Outcome- Health Related Quality of Life
timeFrame: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
measure: Depressive Cognitions
timeFrame: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
measure: Physical Outcome
timeFrame: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
measure: Self-Management- Sleep- Subjective
timeFrame: Change Measured over 9 months of the study (baseline, 3 months, 6 months, 9 months after baseline
measure: Positive Health Practices
timeFrame: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
measure: Depressive Symptoms
timeFrame: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
Secondary outcomes:
measure: Number of Technology-Dependent Children With ER Visits
timeFrame: Up to 9 months
measure: Number of Technology-Dependent Children With Rehospitalizations
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: Frances Payne Bolton School of Nursing, Case Western Reserve University
name: Valerie A. Toly, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: