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A Psychological Intervention for Family Caregivers of Palliative Care Patients

29. august 2019 opdateret af: 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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

154

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Valencia, Spanien, 46010
        • Universitat de València

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control group
Group pf participants that received usual psychological attention.
Eksperimentel: Experimental group
Group of participants that received usual psychological attention plus the structured psychological intervention prosed in the study.
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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Pilar Barreto Martin, PhD, Universitat de València

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. maj 2016

Primær færdiggørelse (Faktiske)

31. maj 2019

Studieafslutning (Faktiske)

31. juli 2019

Datoer for studieregistrering

Først indsendt

28. august 2019

Først indsendt, der opfyldte QC-kriterier

29. august 2019

Først opslået (Faktiske)

3. september 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • PSI2010-19426

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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