- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04676984
Medication Use and Quality of Life Among Older People (Pilot)
연구 개요
상세 설명
In a pragmatic randomized controlled trial, this project will test whether a comprehensive and patient-centered deprescribing intervention can improve quality of life among older people with limited life expectancy. This registration concerns the initial pilot study. All patients included in the pilot study will receive the intervention (that is, the pilot study will not include randomization).
The intervention will comprise a series of consultations between the patient and general practitioner (GP) (at least three) to continuously adjust the patient's medication according to the patient's goals, needs, and preferences, thereby ensuring alignment with the patient's priorities. Thus, the purpose of this intervention is to initiate and facilitate a continued deprescribing process. The process can be summarized in seven steps: During an initial consultation (1: Consultation 0), the GP assesses patient eligibility. If the patient would like to participate, a project nurse subsequently visits the patient at home (2: Home visit) for retrieval of informed consent as well as baseline measurements. During the next consultation (3: Consultation 1), the patient and GP discuss how the patient feels about his/her medical treatment, and the GP provides the patient with written material for the patient to prepare prior to the next consultation. The patients prepares (4: Preparation) by considering and verbalizing his/her goals of care and treatment preferences. Simultaneously, a clinical pharmacist examines the patient's medication list and provides suggestions to the GP on which drugs can be continued and deprescribed, respectively. During the next consultation (5: Consultation 2), the patient and GP discuss the patient's preferences and initiate deprescribing initiatives aligned with the patient's priorities. During a new consultation (6: Consultation 3), the patient and GP follow up on the changes initiated and initiate new deprescribing initiatives if such can be identified. If needed, subsequent consultations (7: Consultation X) are planned until the patient and GP consider the patient's medical treatment optimal.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Region Of Southern Denmark
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Odense, Region Of Southern Denmark, 덴마크, 5000
- Odense University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
- Aged ≥80 years
- Take ≥8 different medications
- Have a life expectancy of <2 years, estimated via the Surprise Question ("Would you be surprised if this patient died within 1-2 years?") by the general practitioner
- Have a Mini-Mental State Exam (MMSE) score of ≥15
- Are able to provide informed consent
Exclusion Criteria:
- Not able to communicate
- Does not speak and understand Danish
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Consultations
The intervention will comprise a series of consultations between the patient and general practitioner (at least three), where the patient and general practitioner will continuously adjust the patient's medication according to the patient's goals, needs, and preferences.
|
The intervention will comprise a series of consultations between the patient and general practitioner (at least three), where the patient and general practitioner will continuously adjust the patient's medication according to the patient's goals, needs, and preferences.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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HEALTH-RELATED QUALITY OF LIFE
기간: Baseline
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Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
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Baseline
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CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 3 MONTHS
기간: 3 months
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Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
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3 months
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CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 6 MONTHS
기간: 6 months
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Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
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6 months
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HEALTH-RELATED QUALITY OF LIFE (DEPRESSION)
기간: Baseline
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Health-related quality of life will be measured using the Danish version of the Depression List.
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Baseline
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CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 3 MONTHS
기간: 3 months
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Health-related quality of life will be measured using the Danish version of the Depression List.
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3 months
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CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 6 MONTHS
기간: 6 months
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Health-related quality of life will be measured using the Danish version of the Depression List.
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6 months
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MORTALITY
기간: 3 months
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Mortality will be assessed through the nationwide Danish Central Person Registry.
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3 months
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MORTALITY
기간: 6 months
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Mortality will be assessed through the nationwide Danish Central Person Registry.
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6 months
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MORTALITY
기간: 12 months
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Mortality will be assessed through the nationwide Danish Central Person Registry.
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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기능적 수준
기간: 기준선, 3개월 및 6개월
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기능적 수준은 Vulnerable Elders Survey 13(VES-13)의 덴마크 버전을 사용하여 측정됩니다.
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기준선, 3개월 및 6개월
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핸드 그립 강도
기간: 기준선, 3개월 및 6개월
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손 악력은 손 악력계를 사용하여 측정됩니다.
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기준선, 3개월 및 6개월
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약물 변경 횟수
기간: 3개월, 6개월, 12개월
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약물 변경 횟수는 약물 목록을 통해 평가됩니다.
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3개월, 6개월, 12개월
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COGNITIVE FUNCTION
기간: Baseline, 3 months and 6 months
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Cognitive function will be measured using the Danish version of the Mini-Mental State Examination-2 (MMSE-2) Standard Form.
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Baseline, 3 months and 6 months
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ABILITY TO SIT AND STAND
기간: Baseline, 3 months and 6 months
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Ability to sit and stand will be measured via the 30-second stand-sit-test.
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Baseline, 3 months and 6 months
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NUMBER OF MEDICATIONS DISCONTINUED
기간: 3 months, 6 months and 12 months
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Number of medications dicontinued will be assessed through the medication lists.
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3 months, 6 months and 12 months
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HOSPITAL ADMISSIONS
기간: 3 months, 6 months and 12 months
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Admissions will be assessed through the nationwide Danish National Patient Register.
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3 months, 6 months and 12 months
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HEALTH CARE COSTS
기간: 3 months, 6 months and 12 months
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Health care costs.
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3 months, 6 months and 12 months
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SUCCESS RATE OF THE INTERVENTION
기간: 3 months, 6 months and 12 months
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Succes rate of the intervention.
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3 months, 6 months and 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Anton Pottegård, Prof, apottegaard@health.sdu.dk
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
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