- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04076670
A Psychological Intervention for Family Caregivers of Palliative Care Patients
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.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Valencia, 스페인, 46010
- Universitat de València
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Control group
Group pf participants that received usual psychological attention.
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실험적: Experimental group
Group of participants that received usual psychological attention plus the structured psychological intervention prosed in the study.
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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).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in anxiety (PRE and POST measures)
기간: Baseline up to 3 months
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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
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Change in depression (PRE and POST measures)
기간: Baseline up to 3 months
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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
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Change in burden (PRE and POST measures)
기간: Baseline up to 3 months
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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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Pilar Barreto Martin, PhD, Universitat de València
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- PSI2010-19426
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
완화 치료에 대한 임상 시험
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Psychological intervention for family caregivers of patients at the end of life에 대한 임상 시험
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