- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Ontario
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Hamilton, Ontario, Canada, L8S 1A4
- McMaster Family Practice
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Hamilton, Ontario, Canada, L8W3J6
- Stonechurch Family Health Centre (SFHC)
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The experience of patients, family members, primary health care providers, volunteers and community organizations with the TAPESTRY-CM program
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Experience of enrollment by patients
Délai: 12 weeks
|
Qualitative measure - focus groups/interviews with patients
|
12 weeks
|
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Extent volunteers needed to facilitate PHR set-up
Délai: 12 weeks
|
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
Délai: 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
|
|
Patient interest in digital step tracking devise
Délai: 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
Délai: 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
|
|
Developmental decision evaluation - I
Délai: 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
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12 weeks
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Gina Agarwal, PhD, McMaster University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 14-450
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