- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03533049
mHealth Family Self-Management (myFAMI)
mHealth Family Self-Management Intervention for Parents of Transplanted Children
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
- Children's Hospital of Wisconsin
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Pediatric patients:
- Has undergone a heart, kidney, or liver transplant being discharged home from the hospital
- Has two eligible family members available to answer questions about the patient
Family members will be eligible for participation upon meeting the following inclusion criteria:
- is English speaking (to date the instruments being used have been validated for English speaking participants only)
- is 18 years of age or older
- has a pediatric family member (< 18 years old) who has undergone a heart, kidney, or liver transplant being discharged home from the hospital.
Exclusion Criteria for the family members are:
- presence of significant communication or cognitive impairment that would preclude completion of questionnaires based on self-report; or
- the pediatric family member has experienced a previous transplant based on self report.
Participants unable to speak and read English will be excluded due to the lack of resources to develop the app and communicate via FaceTime in different languages. We will recruit family members from three types of transplant populations to allow for sufficient sample in a limited time frame for this complex pediatric surgery and high-risk population.
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Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: myFAMI intervention
All participants will receive the standard discharge education from their transplant and inpatient care team. Patients who are assigned to the myFAMI group will also have the smartphone application downloaded onto either the family member's smartphone or a study-provided smartphone. Following discharge from the hospital, participants will use the smartphone application to answer nine daily questions regarding tracking family coping, transplant symptoms, family management of child transplant symptoms, and family-management difficulty with medication and follow-up regimen daily for the first 30 days following discharge. |
Patients who are assigned to the myFAMI group will also have the smartphone application downloaded onto either the family member's smartphone or a study-provided smartphone.
Following discharge from the hospital, participants will use the smartphone application to answer nine daily questions regarding tracking family coping, transplant symptoms, family management of child transplant symptoms, and family-management difficulty with medication and follow-up regimen daily for the first 30 days following discharge.
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Aktiv komparator: Control
Family members assigned to the control group (standard care) will receive standard post-discharge follow-up care consisting of discharge education during the transplant hospitalization and at regularly scheduled appointments instructing families to contact the research nurse with problems or questions.
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Patients who are assigned to the myFAMI group will also have the smartphone application downloaded onto either the family member's smartphone or a study-provided smartphone.
Following discharge from the hospital, participants will use the smartphone application to answer nine daily questions regarding tracking family coping, transplant symptoms, family management of child transplant symptoms, and family-management difficulty with medication and follow-up regimen daily for the first 30 days following discharge.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Improve family coping
Tidsramme: 30 days
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Primary family member receiving myFAMI compared to the primary family member receiving standard post-discharge care will have improved post-discharge coping (primary outcome).
Coping will be measured using the post-discharge coping difficulty scale.
Post Discharge Coping Difficulty Scale (PDCDS), 10-item measure, Scale 0-10, Measures parental and family member difficulty coping with stress, recovery, self-care and management, support, and confidence, α= .84
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30 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Decrease healthcare resources
Tidsramme: 30 days
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Primary family member receiving myFAMI compared to the primary family member receiving standard post-discharge care will have decreased use of healthcare resources defined as number of emergency department visits and number or readmissions to the hospital.
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30 days
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Stacee Lerret, PhD, Medical College of Wisconsin
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 1183697
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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