- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04105244
Self-Management in Parents of Technology-Dependent Children
Resourcefulness Intervention to Promote Self-Management in Parents of Technology-Dependent Children
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44106-5065
- University Hospitals Cleveland Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: 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
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Experimental: 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.
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The intervention includes self-help and help-seeking skills.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychological Outcome- Health Related Quality of Life
Time Frame: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
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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.
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Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
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Depressive Cognitions
Time Frame: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
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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.
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Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
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Physical Outcome
Time Frame: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
|
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. |
Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
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Self-Management- Sleep- Subjective
Time Frame: Change Measured over 9 months of the study (baseline, 3 months, 6 months, 9 months after baseline
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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
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Change Measured over 9 months of the study (baseline, 3 months, 6 months, 9 months after baseline
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Positive Health Practices
Time Frame: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
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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.
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Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
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Depressive Symptoms
Time Frame: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
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"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
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Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Technology-Dependent Children with ER Visits and Rehospitalizations
Time Frame: Total over the 9 months the parent is enrolled in the study
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Number of ER Visits and Rehospitalizations of Technology-Dependent Child
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Total over the 9 months the parent is enrolled in the study
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Collaborators and Investigators
Investigators
- Principal Investigator: Valerie A. Toly, PhD, RN, Frances Payne Bolton School of Nursing, Case Western Reserve University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY20181088
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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