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Self-Management in Parents of Technology-Dependent Children

Primary Purpose

Caregivers, Parents, Self-Management

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resourcefulness Training©
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caregivers focused on measuring Mental Health, Physical Health, Technology-Dependent Children

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospitals Cleveland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Attention Control

Resourcefulness Training Intervention©

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Psychological Outcome- Health Related Quality of Life
Mental Health Related Quality of Life (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. A higher PROMIS T-score represents more of the concept being measured or better mental health.
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.
Physical Outcome
Physical Health Related Quality of Life (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. A higher PROMIS T-score represents more of the concept being measured. Higher score means better physical health.
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
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.
Depressive Symptoms
"Patient Reported Outcomes Measurement Information System (PROMIS)Short Form - Depressive Symtoms "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) A higher PROMIS T-score represents more of the concept being measured. Total Score is reported

Secondary Outcome Measures

Number of Technology-Dependent Children with ER Visits and Rehospitalizations
Number of ER Visits and Rehospitalizations of Technology-Dependent Child

Full Information

First Posted
July 22, 2019
Last Updated
January 11, 2023
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04105244
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
December 21, 2022 (Actual)
Study Completion Date
December 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregivers, Parents, Self-Management, Chronic Illnesses, Multiple
Keywords
Mental Health, Physical Health, Technology-Dependent Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The proposed study is a longitudinal (9-month) 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.
Masking
ParticipantOutcomes Assessor
Masking Description
Data collectors and participants will be blinded to group assignment.
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention Control
Arm Type
No Intervention
Arm Description
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
Arm Title
Resourcefulness Training Intervention©
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Resourcefulness Training©
Intervention Description
The intervention includes self-help and help-seeking skills.
Primary Outcome Measure Information:
Title
Psychological Outcome- Health Related Quality of Life
Description
Mental Health Related Quality of Life (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. A higher PROMIS T-score represents more of the concept being measured or better mental health.
Time Frame
Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
Title
Depressive Cognitions
Description
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.
Time Frame
Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
Title
Physical Outcome
Description
Physical Health Related Quality of Life (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. A higher PROMIS T-score represents more of the concept being measured. Higher score means better physical health.
Time Frame
Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
Title
Self-Management- Sleep- Subjective
Description
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
Time Frame
Change Measured over 9 months of the study (baseline, 3 months, 6 months, 9 months after baseline
Title
Positive Health Practices
Description
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.
Time Frame
Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
Title
Depressive Symptoms
Description
"Patient Reported Outcomes Measurement Information System (PROMIS)Short Form - Depressive Symtoms "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) A higher PROMIS T-score represents more of the concept being measured. Total Score is reported
Time Frame
Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
Secondary Outcome Measure Information:
Title
Number of Technology-Dependent Children with ER Visits and Rehospitalizations
Description
Number of ER Visits and Rehospitalizations of Technology-Dependent Child
Time Frame
Total over the 9 months the parent is enrolled in the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie A. Toly, PhD, RN
Organizational Affiliation
Frances Payne Bolton School of Nursing, Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Resource Sharing Plan: We support the principles, responsibilities and oversight of data sharing as articulated in the Final NIH Statement on Sharing Research Data (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). Once all data are collected, the research team will work to establish a database for the purpose of implementation of these standards, but with an emphasis upon the safeguarding of patient privacy, maintaining scientific integrity, and ensuring database privacy and security. Our goals will be to support the NIH intent of promoting dissemination of research findings and reagents to benefit NIH researchers country-wide and to promote rapid dissemination of clinical research findings. 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.
IPD Sharing 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.
IPD Sharing Access Criteria
Must enter into data use agreement with Case Western Reserve University and the investigators.

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Self-Management in Parents of Technology-Dependent Children

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