Self-Management in Parents of Technology-Dependent Children

NCT ID: NCT04105244

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-08
• Study Completion Date: 2022-12-21

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.

Conditions

Caregivers; Parents; Self-Management; Chronic Illnesses, Multiple

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Attention Control

The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns

Group Type: NO_INTERVENTION

No interventions assigned to this group

Resourcefulness Training Intervention©

The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing.

Group Type: EXPERIMENTAL

Resourcefulness Training©

Intervention Type: BEHAVIORAL

The intervention includes self-help and help-seeking skills.

Interventions

Resourcefulness Training©

The intervention includes self-help and help-seeking skills.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Valerie Toly

Assistant Professor of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valerie A. Toly, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Frances Payne Bolton School of Nursing, Case Western Reserve University

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01NR017614

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY20181088

Identifier Type: -

Identifier Source: org_study_id