- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03301831
Resourcefulness Intervention With Parents of Technology-Dependent Children
27. september 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
93
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ohio
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Cleveland, Ohio, Forente stater, 44106-5065
- University Hospitals Cleveland Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
Cognitive-behavioral intervention that includes personal and social resourcefulness skills.
|
Ingen inngripen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Depressive Cognitions Scale
Tidsramme: 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.
|
From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Medical Outcomes Short Form Health Survey (SF-12) Physical Health
Tidsramme: 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.
|
From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Medical Outcomes Short Form Health Survey (SF-12) Mental Health
Tidsramme: 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.
|
From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Feetham Family Functioning Survey
Tidsramme: 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
Tidsramme: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Valerie A Toly, PhD, Frances Payne Bolton School of Nursing, Case Western Reserve University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
5. februar 2018
Primær fullføring (Faktiske)
9. desember 2019
Studiet fullført (Faktiske)
9. desember 2019
Datoer for studieregistrering
Først innsendt
24. september 2017
Først innsendt som oppfylte QC-kriteriene
28. september 2017
Først lagt ut (Faktiske)
4. oktober 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. oktober 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. september 2021
Sist bekreftet
1. september 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 08-10-30
- 1R15NR017302-01 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
The study team is still conducting analysis and writing up study results for publication.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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