- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Salamanca., Hiszpania, 37003
- Primary care Research unit. La Alamedilla health centre
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Brak interwencji: Kontrola
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Eksperymentalny: 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.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in caregivers will be the principal measure:
Ramy czasowe: 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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Współpracownicy i badacze
Śledczy
- Główny śledczy: Rodriguez-Sanchez Emiliano, MD, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain.
- Krzesło do nauki: Mora-Simón Sara, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain.
- Krzesło do nauki: Porras-Santos Nieves, La Alamedilla Health Center, Castilla y León Health Service - SACYL, Salamanca, Spain.
- Krzesło do nauki: Patino-Alonso M. Carmen, MD, Departamento de Estadística. Universidad de Salamanca. Salamanca. Spain.
- Krzesło do nauki: Recio-Rodríguez José-Ignacio, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
- Krzesło do nauki: Becerro-Muñoz Concepción, MD, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
- Krzesło do nauki: Pérez-Arachaederra Diana, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
- Krzesło do nauki: Gómez-Marcos Manuel-Ángel, md, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
- Dyrektor Studium: García Ortiz Luís, MD, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- GRS270A08
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