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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ontario
-
Hamilton、Ontario、カナダ、L8S 1A4
- McMaster Family Practice
-
Hamilton、Ontario、カナダ、L8W3J6
- Stonechurch Family Health Centre (SFHC)
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The experience of patients, family members, primary health care providers, volunteers and community organizations with the TAPESTRY-CM program
時間枠：12 weeks
|
Qualitative measure and chart audit evaluating the experience of all participants in the pilot
|
12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Experience of enrollment by patients
時間枠：12 weeks
|
Qualitative measure - focus groups/interviews with patients
|
12 weeks
|
|
Extent volunteers needed to facilitate PHR set-up
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Gina Agarwal, PhD、McMaster University
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。