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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Ontario
-
Hamilton, Ontario, Canadá, L8S 1A4
- McMaster Family Practice
-
Hamilton, Ontario, Canadá, L8W3J6
- Stonechurch Family Health Centre (SFHC)
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The experience of patients, family members, primary health care providers, volunteers and community organizations with the TAPESTRY-CM program
Prazo: 12 weeks
|
Qualitative measure and chart audit evaluating the experience of all participants in the pilot
|
12 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Experience of enrollment by patients
Prazo: 12 weeks
|
Qualitative measure - focus groups/interviews with patients
|
12 weeks
|
|
Extent volunteers needed to facilitate PHR set-up
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Gina Agarwal, PhD, McMaster University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 14-450
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .