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TAPESTRY for People With Cardiovascular and Metabolic Disease: A Pilot Study (TAPESTRY-CM)

2016年9月13日 更新者:McMaster University

Teams Advancing Patient Experience: Strengthening Quality for People With Cardiovascular and Metabolic Disease (TAPESTRY-CM): A Pilot Study

TAPESTRY-CM pilot study is a 12-week pilot test of the TAPESTRY-CM using a web application (APP) to help patient manage their diabetes and hypertension and other chronic conditions by assisting them in setting goals and connecting them to their healthcare team.

研究概览

地位

完全的

详细说明

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.

研究类型

介入性

注册 (实际的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ontario
      • Hamilton、Ontario、加拿大、L8S 1A4
        • McMaster Family Practice
      • Hamilton、Ontario、加拿大、L8W3J6
        • Stonechurch Family Health Centre (SFHC)

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

55年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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
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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The experience of patients, family members, primary health care providers, volunteers and community organizations with the TAPESTRY-CM program
大体时间:12 weeks
Qualitative measure and chart audit evaluating the experience of all participants in the pilot
12 weeks

次要结果测量

结果测量
措施说明
大体时间
Experience of enrollment by patients
大体时间:12 weeks
Qualitative measure - focus groups/interviews with patients
12 weeks
Extent volunteers needed to facilitate PHR set-up
大体时间:12 weeks
Quantitaive measures: technology skills self-assessment scale (volunteers) scale, Qualitative measure: usability testing, and documentation of help-line inquiries
12 weeks
Burden on healthcare providers to respond to PHR queries from patients
大体时间:12 weeks
Qualitative measure - focus groups and interviews with involved healthcare providers to assess the role of or burden on healthcare providers.
12 weeks
Patient interest in digital step tracking devise
大体时间:12 weeks
Measure 1: yes/no data from App; Measure 2: qualitative- focus groups or interviews to test the usability of activity trackers.
12 weeks
Feasibility of using a structured goal setting process with patients including a formal Goal Attainment Scaling
大体时间:12 weeks
Qualitative: focus groups or interviews and patient enablement scores; Quantitative: Using Goal Attainment Scales, to assess the usability of Goal Attainment Scaling;
12 weeks
Developmental decision evaluation - I
大体时间:12 weeks
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
12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Gina Agarwal, PhD、McMaster University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年12月1日

初级完成 (实际的)

2015年9月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2014年12月3日

首先提交符合 QC 标准的

2016年3月16日

首次发布 (估计)

2016年3月23日

研究记录更新

最后更新发布 (估计)

2016年9月15日

上次提交的符合 QC 标准的更新

2016年9月13日

最后验证

2016年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 14-450

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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