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| ID | Type | Description | Link |
|---|---|---|---|
| 1R15NR017302-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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Technology-dependent children, those who live at home but rely on medical equipment such as mechanical ventilation or feeding tubes, require complex care for their chronic condition. Parents usually provide a majority of their care and are often overwhelmed by the caregiving demands resulting in deterioration of their own mental and physical health. The goal of this 2-arm (intervention vs. attention control) RCT is to test a cognitive-behavioral Resourcefulness Training intervention that includes teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment. The intervention is proposed to improve these caregivers' mental and physical health outcomes and family functioning outcomes while they continue to provide vital care for these vulnerable children.
Technology-dependent children, those who rely on medical equipment such as mechanical ventilation or feeding tubes for daily care at home, are among the sickest and most vulnerable subset of children with complex chronic conditions. An estimated 600,000 children in the United States are technology dependent and live at home, and are cared for primarily by their parents. These parents report greater levels of depressive symptoms and stress than other caregiver groups. In addition, these caregivers report poor psychological and physical health that compromise their caregiving capacity and increase their use of emergency rooms (ER) for their children's care needs. Despite these adverse consequences, there are no interventions to meet the needs of these caregivers and their children. 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. It will be tested in a randomized trial against an attention-only control arm. The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment. The Attention Control arm 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 Resourcefulness Training versus Attention Control improves psychological (general mental health, depressive cognitions, depressive symptoms, appraised stress, burden) and physical outcomes (general physical health, chronic stress [hair cortisol]) and family functioning over 6 months in parents of technology-dependent children, after controlling for the parents' race/ethnicity, sex, family income, and children's functional status; and 2) Determine whether changes in psychological and physical outcomes and family functioning are mediated by changes in parents' levels of resourcefulness (personal and social). Data collection will take place at baseline then 6 weeks, 3 months, and 6 months post-enrollment. Our study will be the first to test a resourcefulness intervention for this caregiver population and to include male as well as female caregivers. This intervention is distinctive in that it uses web, telephone, and journal components for reinforcement-not multiple face-to-face visits that can be labor intensive. If shown to be efficacious, it can be easily replicated with other populations with strong potential for translation into practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resourcefulness Training Intervention | Experimental | The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment. |
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| 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 any usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resourcefulness Training | Behavioral | Cognitive-behavioral intervention that includes personal and social resourcefulness skills. |
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| Measure | Description | Time Frame |
|---|---|---|
| Depressive Cognitions Scale | Subjective measure of participant depressive cognitions- precursor of depressive symptoms. Score range for the instrument is 0-40, where a higher score indicates greater depressive cognition. | From baseline to 6 weeks, 3 months, and 6 months post-enrollment |
| Medical Outcomes Short Form Health Survey (SF-12) Physical Health | Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health. | From baseline to 6 weeks, 3 months, and 6 months post-enrollment |
| Medical Outcomes Short Form Health Survey (SF-12) Mental Health | Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health. | From baseline to 6 weeks, 3 months, and 6 months post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Feetham Family Functioning Survey | Change in Family Functioning from Baseline to 6 Months Post Enrollment. This subjective measure of family functioning is collected via participant survey. The score range is 0-175, which is the sum of the "differences" between reality and life expectations. Higher 'Difference' score indicates an imbalance between reality and life expectations | From baseline to 6 weeks, 3 months, and 6 months post-enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valerie A Toly, PhD | Frances Payne Bolton School of Nursing, Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106-5065 | United States |
The study team is still conducting analysis and writing up study results for publication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Resourcefulness Training Intervention | The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment. Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills. |
| FG001 | 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 any usual care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Resourcefulness Training Intervention | The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment. Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depressive Cognitions Scale | Subjective measure of participant depressive cognitions- precursor of depressive symptoms. Score range for the instrument is 0-40, where a higher score indicates greater depressive cognition. | Posted | Mean | Full Range | Score on a Scale | From baseline to 6 weeks, 3 months, and 6 months post-enrollment |
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No adverse events were reported during the 6 month data collection period.
The definitions do not differ in this context because no adverse events or serious adverse events were reported during the 6 month data collection period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Resourcefulness Training Intervention | The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment. Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valerie Boebel Toly, PhD, RN, CPNP | Case Western Reserve University | (216) 368-3082 | vab@case.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2018 | Sep 27, 2021 | Prot_SAP_004.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D000071069 | Multiple Chronic Conditions |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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2-arm RCT with participants randomized to either the intervention or attention control group.
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| Resourcefulness Scale | Subjective survey of participants' personal and social resourcefulness. Score range is 0-140, where a higher score indicates greater resourcefulness. | From baseline to 6 weeks, 3 months, and 6 months post-enrollment |
| Withdrawal by Subject |
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| BG001 | 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 any usual care. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| General Physical Health | Subjective Measure that is part of SF-12 survey that participants complete. The score range is 0-100, 0 indicates lowest level of health, 100 indicates highest level of health. | Mean | Full Range | units on a scale |
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| General Mental Health | General Mental Health is a subjective survey that is part of the SF-12 Scale completed by participants. The score range is 0-100, 0 indicates lowest level of health, 100 indicates highest level of health. | Mean | Full Range | units on a scale |
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| Center for Epidemiological Studies- Depression | This is commonly know as the CES-D. It is a subjective measure of depressive symptoms. Data is obtained via survey of participants. The score range is 0-60, Higher score indicates the presence of more symptomatology (more depressive symptoms). | Mean | Full Range | units on a scale |
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| Resourcefulness Scale | This subjective measure is collected via participant surveys. Score range is 0-140, higher score indicates greater resourcefulness. | Mean | Full Range | Score on a scale |
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| Depressive Cognitions Scale | This is a subjective measure that is collected from participants via survey. Score range is 0-40, Higher Score indicates greater depressive cognition. | Mean | Full Range | units on a scale |
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| Feetham Family Functioning Survey | This subjective measure of family functioning is collected via participant survey. The score range is 0-175, which is the sum of the "differences" between reality and life expectations. Higher 'Difference' score indicates an imbalance between reality and life expectations | Mean | Standard Deviation | units on a scale |
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| Zarit Burden Scale | This is a subjective measure collected via participant survey. Score range is 0-48, higher score indicates greater burden. | Mean | Full Range | units on a scale |
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| OG001 | 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 any usual care. |
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| Primary | Medical Outcomes Short Form Health Survey (SF-12) Physical Health | Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health. | Posted | Mean | Full Range | Score on a Scale | From baseline to 6 weeks, 3 months, and 6 months post-enrollment |
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| Primary | Medical Outcomes Short Form Health Survey (SF-12) Mental Health | Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health. | Posted | Mean | Full Range | Score on a Scale | From baseline to 6 weeks, 3 months, and 6 months post-enrollment |
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| Secondary | Feetham Family Functioning Survey | Change in Family Functioning from Baseline to 6 Months Post Enrollment. This subjective measure of family functioning is collected via participant survey. The score range is 0-175, which is the sum of the "differences" between reality and life expectations. Higher 'Difference' score indicates an imbalance between reality and life expectations | Posted | Mean | Standard Deviation | Score on a Scale | From baseline to 6 weeks, 3 months, and 6 months post-enrollment |
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| Secondary | Resourcefulness Scale | Subjective survey of participants' personal and social resourcefulness. Score range is 0-140, where a higher score indicates greater resourcefulness. | Posted | Mean | Full Range | Score on a Scale | From baseline to 6 weeks, 3 months, and 6 months post-enrollment |
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| 0 |
| 46 |
| 0 |
| 47 |
| 0 |
| 46 |
| EG001 | 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 any usual care. | 0 | 47 | 0 | 46 | 0 | 47 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 6 Months Post Enrollment Timepoint 4 |
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| 6 Weeks Post-Enrollment, Timepoint 4 |
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| 6 Months Post Enrollment Timepoint |
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| 6 Months Post Enrollment Timepoint |
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