N/A
N=197
Self-Management in Parents of Technology-Dependent Children
Caregivers · Parents · Self-Management · Chronic Illnesses, Multiple
Bottom Line
View on ClinicalTrials.gov: NCT04105244 ↗Enrolled (actual)
197
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Psychological Outcome- Health Related Quality of Life — 40.5; 37.0; 41.9; 39.70 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resourcefulness Training© (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Psychological Outcome- Health Related Quality of Life |
40.5; 37.0; 41.9; 39.70; 41.7; 40.70 | <0.05 sig |
| PRIMARY Depressive Cognitions |
6.31; 8.27; 6.93; 8.62; 6.13; 8.17 | <0.05 sig |
| PRIMARY Physical Outcome |
44.90; 44.00; 46.00; 45.00; 45.00; 46.10 | <0.05 sig |
| PRIMARY Self-Management- Sleep- Subjective |
7.134; 7.59; 6.278; 6.768; 6.058; 6.406 | — |
| PRIMARY Positive Health Practices |
64.515; 64.4; 65.767; 65.811; 66.805; 67.352 | — |
| PRIMARY Depressive Symptoms |
51.80; 55.10; 51.00; 53.10; 50.10; 52.20 | <0.05 sig |
| SECONDARY Number of Technology-Dependent Children With ER Visits |
0.9592; 0.9108 | <0.05 sig |
| SECONDARY Number of Technology-Dependent Children With Rehospitalizations |
0.7755; 0.8415 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04105244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.