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Intervention in Groups of Family Caregivers in Primary Health Care (IGFC)

VALIDATION OF AN INTERVENTION EFFECTIVE IN GROUPS OF FAMILY CAREGIVERS OF DEPENDENT PATIENTS FOR THEIR APPLICATION IN CENTRES OF PRIMARY HEALTH CARE.

Although Primary Health Care (PHC) Teams are used to deal with prevention and treatment of sanitary problems in adults with chronic diseases, they usually have a lack of experience in development of psychotherapeutic interventions. However, these interventions are the ones that achieve better results to reduce symptomatology and improve emotional state of caregivers.

The study aims to evaluate the effectiveness of an intervention of psychotherapy in improving the mental health and quality of life of caregivers. This intervention is based on theoretical approaches to care adjusted to cognitive theory, in order to be applied in primary health care centres.

To assess a cognitive-behavioural intervention to modify dysfunctional thoughts to properly face the care.

Studieoversikt

Status

Ukjent

Forhold

Detaljert beskrivelse

Methods/Design: Design: This is multicentre cross-sectional study, randomized in two parallel groups.

Setting: Two different urban PHC. Study population: 150 caregivers will be included by consecutive sampling. They provide mostly all the assistance to care-dependent familiars receiving attention in PHC Centers. Of chance form 100 caregivers will be assigned to the experimental group and 50 to the group control.

Measurements: Each caregiver will be evaluated on a personal interview. The caregivers' assessment protocol: 1) Assessment of different socio-demographic related to care, and caregiver's personal situation. 2)Care-dependent individuals will also be assessed by Barthel Index and Pfeiffer Questionnaire (SPMSQ). 3)Change in caregivers will be the principal measure: family function (Family APGAR Questionnaire), burden short questionnaire (Short Zarit Burden Interview), quality of life (Ruiz & Baca: 1993 Questionnaire), the Duke-UNK Functional Social Support Questionnaire, the General Health Questionnaire-12, and changes in Dysfunctional Thoughts about caring. 4) Intervention implementation measures will also be assessed.

Intervention: A psychotherapeutic intervention will be 8 sessions of 90 minutes in a pilot study groups. This intervention has been initially developed for family caregivers of patients with dementia.

Discussion: Psychotherapeutic interventions have been proved to obtain better results to reduce symptomatology and improve emotional state of caregivers. Moreover, this intervention has been proved to be effective in a different setting other than PHC, and was developed by professionals of Mental Health. If we found that this intervention is effective in PHC and with our professionals, it would be an important instrument to offer to caregivers of care-dependent patients.

Studietype

Intervensjonell

Registrering (Forventet)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

      • Salamanca., Spania, 37003
        • Primary care Research unit. La Alamedilla health centre

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

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Caregivers: They provide mostly all the assistance to care-dependent familiars receiving attention in PHC Centers

Exclusion Criteria:

  • Those persons who did not share their place of residence with the relative, or who were impossible to locate either due to a change of address or being admitted to hospital or a nursing home, or on account of the patient's death were excluded

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Styre
Eksperimentell: psychotherapy

The study aims to evaluate the effectiveness of an intervention of psychotherapy in improving the mental health of caregivers.

This intervention is based on theoretical approaches to care adjusted to cognitive theory, in order to be applied in primary health care centres.

A psychotherapeutic intervention will be 8 sessions of 90 minutes in a pilot study groups. This intervention has been initially developed for family caregivers of patients with dementia.
Andre navn:
  • Received usual care.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in caregivers will be the principal measure:
Tidsramme: Initial and 6 months later
family function (Family APGAR Questionnaire), burden short questionnaire (Short Zarit Burden Interview), quality of life (Ruiz & Baca: 1993 Questionnaire), the Duke-UNK Functional Social Support Questionnaire, the General Health Questionnaire-12, and changes in Dysfunctional Thoughts about caring.
Initial and 6 months later

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Rodriguez-Sanchez Emiliano, MD, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain.
  • Studiestol: Mora-Simón Sara, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain.
  • Studiestol: Porras-Santos Nieves, La Alamedilla Health Center, Castilla y León Health Service - SACYL, Salamanca, Spain.
  • Studiestol: Patino-Alonso M. Carmen, MD, Departamento de Estadística. Universidad de Salamanca. Salamanca. Spain.
  • Studiestol: Recio-Rodríguez José-Ignacio, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
  • Studiestol: Becerro-Muñoz Concepción, MD, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
  • Studiestol: Pérez-Arachaederra Diana, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
  • Studiestol: Gómez-Marcos Manuel-Ángel, md, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
  • Studieleder: García Ortiz Luís, MD, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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

1. september 2008

Primær fullføring (Forventet)

1. juni 2009

Studiet fullført (Forventet)

1. september 2010

Datoer for studieregistrering

Først innsendt

30. juli 2010

Først innsendt som oppfylte QC-kriteriene

5. august 2010

Først lagt ut (Anslag)

9. august 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. august 2010

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. august 2010

Sist bekreftet

1. august 2010

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GRS270A08

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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