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Resourcefulness Intervention With Parents of Technology-Dependent Children
27 september 2021 bijgewerkt door: Valerie Toly, University Hospitals Cleveland Medical Center
Intervention Pilot With Parents of Technology-Dependent Children
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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
93
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44106-5065
- University Hospitals Cleveland Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- parent 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 ventilator; Group 2, intravenous nutrition/medication; Group 3 respiratory or nutritional support)
- at least 18 years of age
- able to speak and understand English due to the availability of the intervention and instruments in English only
- the technology-dependent child must be age 17 years or younger and receive care in the home from his/her parent
Exclusion Criteria:
- Parents of children with a cancer diagnosis will be excluded from participation due to the potentially life-threatening, terminal nature of the illness and grief reactions associated with a cancer diagnosis that may limit their ability to participate over the 6 month study.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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.
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Cognitive-behavioral intervention that includes personal and social resourcefulness skills.
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Geen tussenkomst: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Depressive Cognitions Scale
Tijdsspanne: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
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.
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From baseline to 6 weeks, 3 months, and 6 months post-enrollment
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Medical Outcomes Short Form Health Survey (SF-12) Physical Health
Tijdsspanne: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
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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.
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From baseline to 6 weeks, 3 months, and 6 months post-enrollment
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Medical Outcomes Short Form Health Survey (SF-12) Mental Health
Tijdsspanne: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
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.
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From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Feetham Family Functioning Survey
Tijdsspanne: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
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
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From baseline to 6 weeks, 3 months, and 6 months post-enrollment
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Resourcefulness Scale
Tijdsspanne: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
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Subjective survey of participants' personal and social resourcefulness.
Score range is 0-140, where a higher score indicates greater resourcefulness.
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From baseline to 6 weeks, 3 months, and 6 months post-enrollment
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Valerie A Toly, PhD, Frances Payne Bolton School of Nursing, Case Western Reserve University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
5 februari 2018
Primaire voltooiing (Werkelijk)
9 december 2019
Studie voltooiing (Werkelijk)
9 december 2019
Studieregistratiedata
Eerst ingediend
24 september 2017
Eerst ingediend dat voldeed aan de QC-criteria
28 september 2017
Eerst geplaatst (Werkelijk)
4 oktober 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
25 oktober 2021
Laatste update ingediend die voldeed aan QC-criteria
27 september 2021
Laatst geverifieerd
1 september 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 08-10-30
- 1R15NR017302-01 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
The study team is still conducting analysis and writing up study results for publication.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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