Self-Management in Parents of Technology-Dependent Children

NCT04105244 | Completed Results DMC

• 2 other identifiers: STUDY20181088R01NR017614
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Mental Health; Physical Health; Technology-Dependent Children

Outcome Measures

Primary Outcomes (6)

• Psychological Outcome- Health Related Quality of Life

  Mental Health Related Quality of Life (The Patient-Reported Outcomes Measurement Information System \[PROMIS\] Short Form version 1.2- Global Health). Ten (10) Items. Score Range: 10 - 50. Global Mental Health (GMH) score converted to a T-Score metric - produces a physical and a mental health score. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. A higher PROMIS T-score represents more of the concept being measured or better mental health.

  Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline

• Depressive Cognitions

  Screening Measure for Early Detection of Depressive Symptoms: The Depressive Cognition Scale. Measures depressive cognitions and negative thoughts that may lead to clinical depression. Eight (8) Items. Score Range: 0 - 40. Higher scores indicating more depressive cognitions.

  Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline

• Physical Outcome

  (The Patient-Reported Outcomes Measurement Information System \[PROMIS\] Short Form version 1.2- Global Health). Ten (10) Items. Score Range: 10 - 50. Global Physical Health (GPH) score converted to a T-Score metric - produces a physical health score. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. Higher T-score means better physical health.

  Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline

• Self-Management- Sleep- Subjective

  Appraised Sleep Quality (Pittsburgh Sleep Quality Index), Pittsburgh Sleep Quality Index The Pittsburgh Sleep Quality Index (PSQI). Assesses sleep quality and disturbances over a l-month time interval. Nineteen (19) items are grouped into seven component scores, each weighted equally on a 0-3 scale. Score Range (Global PSQI Score) is 0-21. Higher scores indicate worse sleep quality. Sub Scales are summed

  Change Measured over 9 months of the study (baseline, 3 months, 6 months, 9 months after baseline

• Positive Health Practices

  Personal Lifestyle Questionnaire- Positive Health Practices Personal Lifestyle Questionnaire (PLQ). Measures the positive health practices of exercise, substance use, nutrition, relaxation, safety, and health promotion. Twenty-four (24) items 4-point summated rating scale with a range of possible scores from 24 to 96 Higher scores reflect the practice of more health behaviors. Total scores are reported.

  Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline

• Depressive Symptoms

  "Patient Reported Outcomes Measurement Information System (PROMIS)Short Form - Depressive Symptoms "Patient Reported Outcomes Measurement Information System (PROMIS)Short Form Version 1.0 - Depression 8a. Assess self-reported negative mood , views of self , social cognition, and decreased positive affect and engagement." Eight (8) Items. Score Range: 5 (Min)-40 (Max). Total Score is reported. The score is converted to a T-Score metric. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. A higher PROMIS T-score represents more of the concept (depression) being measured thus a T-score of 60 is one standard deviation worse related to the concept of depression than average.

  Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline

Secondary Outcomes (2)

• Number of Technology-Dependent Children With ER Visits

  Up to 9 months

• Number of Technology-Dependent Children With Rehospitalizations

  Up to 9 months

Study Arms (2)

Attention Control

NO INTERVENTION

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

Resourcefulness Training Intervention©

EXPERIMENTAL

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.

Behavioral: Resourcefulness Training©

Interventions

Resourcefulness Training© BEHAVIORAL

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

Resourcefulness Training Intervention©

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Multiple Chronic Conditions; Psychological Well-Being

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Limitations and Caveats

A majority of our study recruitment, enrollment, and data collection occurred during the Pandemic (2020-2021) therefore the protocol was modified to comply with the lockdown public health measures and the IRB mandate. All components of the study were conducted virtually using an institutional review board (IRB) approved videochat platform, REDCap, telephone, and text beginning in June 2020.

Results Point of Contact

• Title: Valerie Boebel Toly, PhD, RN, CPNP-PC, FAAN
• Organization: Frances Payne Bolton School of Nursing, Case Western Reserve University

vab@case.edu

216-534-5844

Study Officials

• Valerie A. Toly, PhD, RN

  Frances Payne Bolton School of Nursing, Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Data collectors and participants will be blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nursing

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: September 26, 2019
• Study Start: July 8, 2019
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: June 6, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: The data will be shared once all Human Subject identifiers are removed and preliminary analyses have been completed and collaborative ventures will be explored with the other investigators.
• Access Criteria: Must enter into data use agreement with Case Western Reserve University and the investigators.

Locations

US (1)