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N/A Completed N=197 Randomized Double-blind Treatment

Self-Management in Parents of Technology-Dependent Children

Caregivers · Parents · Self-Management · Chronic Illnesses, Multiple
Source: ClinicalTrials.gov NCT04105244 ↗
Enrolled (actual)
197
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcomePrimary: Psychological Outcome- Health Related Quality of Life — 40.5; 37.0; 41.9; 39.70 score on a scale — p=<0.05

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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