- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01177696
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Salamanca., Spanien, 37003
- Primary care Research unit. La Alamedilla health centre
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: Kontrollera
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Experimentell: 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in caregivers will be the principal measure:
Tidsram: Initial and 6 months later
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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.
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Initial and 6 months later
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Samarbetspartners och utredare
Utredare
- Huvudutredare: 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
- Studierektor: García Ortiz Luís, MD, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GRS270A08
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