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A Psychological Intervention for Family Caregivers of Palliative Care Patients

29. august 2019 oppdatert av: M. Antonia Pérez-Marín, University of Valencia

Benefits of a Psychological Intervention in Family Caregivers of Palliative Care Patients

This work aims to study the benefits a psychological intervention in family caregivers of palliative care patients can have for reducing anxiety, depression and overburden.

A parallel randomized controlled trial of two groups was performed. Information was collected on 154 family caregivers of patients at the end of life during the moments before and after the intervention.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

154

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Spania
      • Valencia, Spania, 46010
        • Universitat de València

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:

  • To be the main family caregiver of a patient at the end of life, receiven palliative care. In the present study, the main family caregiver is defined as follows: family member who assumes the main tasks of care and attends to the patient most of the time, or for a longer period of time than other members of the family.
  • To have signed the informed consent.

Exclusion Criteria:

• To present cognitive impairment.

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: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Control group
Group pf participants that received usual psychological attention.
Eksperimentell: Experimental group
Group of participants that received usual psychological attention plus the structured psychological intervention prosed in the study.
Annen: Psychological intervention for family caregivers of patients at the end of life
The intervention protocol is a structured programme within the framework of counselling, that aims to reduce anxiety and depression symptoms, as well as symptoms of burden (overburden).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in anxiety (PRE and POST measures)
Tidsramme: Baseline up to 3 months

This variable was assesed with the Hospital Anxiety and Depression Scale, HADS. This Scale contains 7 items asessing anxiety, where lower values represent a better outcome.

In order to observe the change in anxiety, it was measured at two time points:

First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed.

Second measurement: POST. Up to 3 months after the first measurement the second measurement of the same variable was carried out.

Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received the usual psychological attention plus the structured psychological intervention proposed in this study.
Baseline up to 3 months
Change in depression (PRE and POST measures)
Tidsramme: Baseline up to 3 months

This variable was assesed with the Hospital Anxiety and Depression Scale, HADS.

In order to observe the change in depression, it was measured at two time points:

First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed.

Second measurement: POST. Up to 3 months after the first measurement the second measurement of the same variable was carried out.

Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received the usual psychological attention plus the structured psychological intervention proposed in this study.
Baseline up to 3 months
Change in burden (PRE and POST measures)
Tidsramme: Baseline up to 3 months

This variable was assesed with the Zarit Burden Inventory.

In order to observe the change in burden, it was measured at two time points:

First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed.

Second measurement: POST. Up to 3 months after the first measurement the second measurement of the same variable was carried out.

Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received the usual psychological attention plus the structured psychological intervention proposed in this study.
Baseline up to 3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Valencia

Etterforskere

  • Hovedetterforsker: Pilar Barreto Martin, PhD, Universitat de València

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)

31. mai 2016

Primær fullføring (Faktiske)

31. mai 2019

Studiet fullført (Faktiske)

31. juli 2019

Datoer for studieregistrering

Først innsendt

28. august 2019

Først innsendt som oppfylte QC-kriteriene

29. august 2019

Først lagt ut (Faktiske)

3. september 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. september 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. august 2019

Sist bekreftet

1. august 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • PSI2010-19426

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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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