- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02716064
TAPESTRY for People With Cardiovascular and Metabolic Disease: A Pilot Study (TAPESTRY-CM)
Teams Advancing Patient Experience: Strengthening Quality for People With Cardiovascular and Metabolic Disease (TAPESTRY-CM): A Pilot Study
연구 개요
상세 설명
This pilot study is a program evaluation that will employ developmental evaluation techniques to collect qualitative and quantitative data that will be handled, using a sequential explanatory mixed methods approach.Developmental evaluation is particularly useful for pre-formative development of potential scalable interventions. Developmental evaluation tracks and attempts to make sense of what emerges under conditions of complexity, documenting and interpreting the dynamics, interactions, and interdependencies that occur as innovations unfold. It will be helpful to explicitly understand: 1) what important decisions occur during the TAPESTRY-CM intervention development process and; 2) what data have validated those decisions about how the intervention will be structured and delivered. This understanding will provide a basis for describing key decisions and their rationale to our community and to other communities so that they make more informed adaptations to their local context.
TAPESTRY-CM has applied the principles of participatory design by engaging community stakeholders to co-create and refine TAPESTRY-CM interventions in the early phases of the project.
The use of mixed methods was purposefully chosen for this developmental evaluation. Answering a set of related research questions which included the collecting, analyzing and interpreting of qualitative and quantitative data increases the depth of understanding of results, provides stronger evidence for patterns or themes if data converge, can neutralize or cancel out some of the disadvantages of each method alone, and explicitly recognizes that social phenomena are complex such that varied methods are helpful to best understand these complexities.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Hamilton, Ontario, 캐나다, L8S 1A4
- McMaster Family Practice
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Hamilton, Ontario, 캐나다, L8W3J6
- Stonechurch Family Health Centre (SFHC)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients over the age of 55 at the start of the study
- Patients with both diabetes and hypertension
- Patients with access to a computer and the internet
Exclusion Criteria:
- Patient is palliative or receiving end-of-life care
- Patient is deceased
- Has explicitly stated that they do not want to be part of a research project
- Patient resides in long-term care
- Patient has indicated that they do not want to receive a home visit from trained community volunteers.
- Patient or family member does not speak English
- Patient will be out of the country for more than 50% of trial duration
- Patients without access to a computer with the internet
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: TAP-CM Intervention
Patients in this arm will be encouraged to complete the Healthy Lifestyle App modules and use McMaster PHR to self manage their chronic disease.
Participants will also be completing the health and life goals using the App.
The TAPESTRY-CM reports generated will then be reviewed by the clinic huddle teams
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The intervention includes: 1) Healthy Lifestyle App Goal Setting and Prioritization and modules, 2) TAP-CM Report triage Huddle with Interprofessional Team 3) The connection of patients to appropriate community resources 4) Volunteer helping with technology use
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The experience of patients, family members, primary health care providers, volunteers and community organizations with the TAPESTRY-CM program
기간: 12 weeks
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Qualitative measure and chart audit evaluating the experience of all participants in the pilot
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12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Experience of enrollment by patients
기간: 12 weeks
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Qualitative measure - focus groups/interviews with patients
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12 weeks
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Extent volunteers needed to facilitate PHR set-up
기간: 12 weeks
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Quantitaive measures: technology skills self-assessment scale (volunteers) scale, Qualitative measure: usability testing, and documentation of help-line inquiries
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12 weeks
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Burden on healthcare providers to respond to PHR queries from patients
기간: 12 weeks
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Qualitative measure - focus groups and interviews with involved healthcare providers to assess the role of or burden on healthcare providers.
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12 weeks
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Patient interest in digital step tracking devise
기간: 12 weeks
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Measure 1: yes/no data from App; Measure 2: qualitative- focus groups or interviews to test the usability of activity trackers.
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12 weeks
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Feasibility of using a structured goal setting process with patients including a formal Goal Attainment Scaling
기간: 12 weeks
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Qualitative: focus groups or interviews and patient enablement scores; Quantitative: Using Goal Attainment Scales, to assess the usability of Goal Attainment Scaling;
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12 weeks
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Developmental decision evaluation - I
기간: 12 weeks
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mportant decisions during the TAPESTRY-CM intervention development process that affected initial implementation or changes in delivery of the TAP-CM intervention and what data supported the decisions made.
Using a template to record the number and type of decisions, assessed using qualitative and quantitative analysis
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12 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Gina Agarwal, PhD, McMaster University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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