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Using 5 Minute Videos for Numeracy and Literacy Challenged Stroke Survivors to Improve Outcomes

5 de agosto de 2016 atualizado por: Dr. Ayeesha Kamran Kamal, Aga Khan University

Translating Knowledge for Action Against Stroke - Using 5 Minute Videos for Numeracy and Literacy Challenged Stroke Survivors and Caregivers to Improve Outcomes

Two thirds of all strokes happen in developing countries like Pakistan. There is a serious lack of health literacy regarding survival after stroke. We hypothesize that our set of 5 minute videos that teach important skills to stroke survivors and their caregivers , that can be replayed in cell phones for extended learning, will increase their adherence to Medications after stroke and improve the control of blood pressure, elevated cholesterol and glucose in the participants getting cell phone based educational videos.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

In 80% of patients with stroke, further events may be prevented by altering lifestyle behavioral risk, and increasing adherence to medications to control hypertension, diabetes, lipids. Yet, there exists a huge science to implementation gap to adopt these widely recognized beneficial medicines and lifestyle changes. Those most in need remain unable to actualize the benefits of science, due to lack of knowledge, perceived complexity, literacy challenges, limited time by poorly communicating doctors in crowded clinics and essentially, failure by regional scientists to translate Western science in creative resonant ways that enable wider uptake.

In this randomized double blind translational implementation study, we will study the effectiveness of the implementation tactic of delivering enabling stroke education and risk reduction to literacy and numeracy challenged Pakistani stroke survivors and their caregivers, via short films teaching stroke recognition, healthy habits, medication adherence and self-care. These 5 minute films , using a 'show me not tell me ' approach, will be replayed in tablets, and shown to all stroke patients in the intervention arm. The primary objective of this study is to answer the research question - Does video based education given to stroke patients (with mild to moderate disability) and their caregivers before discharge, and during follow up, improve adherence to therapy and control of three major risk factors (Diabetes, hypertension and dyslipidemia) at twelve months post index stroke?

Tipo de estudo

Intervencional

Inscrição (Real)

310

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Paquistão
    • Sindh
      • Karachi, Sindh, Paquistão, 74800
        • Aga Khan University, Clinical Trial Unit

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Adult men and women, > 18 years of age
  2. Resident of Karachi and planning to live in Karachi to complete long term follow up
  3. Able to understand Urdu (language of the videos)
  4. Admitted with first ever stroke (ischemic or hemorrhagic)
  5. Modified Rankin score <3 ( Mild strokes)
  6. Have at least one vascular risk factor that requires medical intervention
  7. Consent to participate in the study and follow up, both stroke and caregiver.
  8. Have a stable surrogate caregiver at home who is responsible for appointments, follow-ups, overall care, e.g., wife, daughters, daughter- in- law, etc.

Exclusion Criteria:

  1. Serious aphasia, visual hemi neglect, short term memory loss in the patient precluding understanding, visualization or retention of the video material, despite overall "a small stroke", this would be a cognitively critical stroke.
  2. Serious aphasia, visual hemi neglect, short term memory loss, dementia in the caregiver precluding understanding, visualization or retention of the video material.
  3. Iatrogenic stroke, stroke due to non-atherosclerotic vascular disease and rare causes e.g. moya moya, carotid dissections, gunshot to neck, post Coronary Artery Bypass surgery etc.
  4. Serious concurrent medical illnesses, like cancer, renal failure, acute liver disease in past 6 months (that precludes use of statins), chronic liver disease, that exclude the use of stroke preventive medications, or require non standardized therapy.
  5. Any use of off label, non-guideline medications, due to patient unique comorbid conditions that interfere with medication compliance to antihypertensive, statins, antiplatelet agents and diabetes control.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Standard Care, Organized Discharge
Stroke patients are given instructions before discharge regarding diet, need for rehabilitation, possible complications, medication use and information booklets are also handed out. This information is imparted by a multidisciplinary team consisting of a neuro physician, a stroke nurse, a dietitian and a physiotherapist. These are verbal instructions and handouts are written in English. On the day of discharge, or 24 hours prior to discharge, a discharge coordinator details the skills learnt . A detailed written discharge summary is given out detailing all aspects of care, follow-up, medications and test results.
Outro: Video Arm
  1. 5 minute videos, on various stroke related topics/ themes delivered in one session before discharge from the hospital (list topics on which videos have to made)
  2. Discussion and questions and answers after viewing video to ensure that core message has been understood and there are no lacunae in understanding the message of video.
  3. Phone card - a memory chip installed in the cell phones of intervention team that ensures that the videos can be replayed at home to refresh memory of some details that may not have been captured in the mandatory viewing sessions.
Experimental: Video Arm, Standard Discharge

Intervention is as follows:

  1. 5 minute videos, on various stroke related topics/ themes delivered in one session before discharge from the hospital (list topics on which videos have to made)
  2. Discussion and questions and answers after viewing video to ensure that core message has been understood and there are no lacunae in understanding the message of video.
  3. Phone card - a memory chip installed in the cell phones of intervention team that ensures that the videos can be replayed at home to refresh memory of some details that may not have been captured in the mandatory viewing sessions.
Outro: Video Arm
  1. 5 minute videos, on various stroke related topics/ themes delivered in one session before discharge from the hospital (list topics on which videos have to made)
  2. Discussion and questions and answers after viewing video to ensure that core message has been understood and there are no lacunae in understanding the message of video.
  3. Phone card - a memory chip installed in the cell phones of intervention team that ensures that the videos can be replayed at home to refresh memory of some details that may not have been captured in the mandatory viewing sessions.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Increase in Adherence and Control of Stroke Risk Factors
Prazo: 1, 3, 6, 9 and 12 months
  1. Proportion of participants adhering to medications prescribed (Definition of adherence- use of prescribed medications on >5 days a week and measured by the Morisky adherence scale(18).
  2. Proportion of participants achieving control of blood pressure (control is defined as BP<125/85), blood sugar (HbA1c<7) and blood cholesterol (LDL < 100)(19).
1, 3, 6, 9 and 12 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Increase in Knowledge and Decrease in Complications
Prazo: 1, 3, 6, 9 and 12 months
  1. Increase in knowledge of caretakers concerning stroke risk factors, stroke rehabilitation and medications (A knowledge questionnaire will be designed to cover all aspects. This will be administered at 1, 3, 6, 9 and 12 months and improvement in score will be ascertained).
  2. Readmission to hospital with any of the stroke related complications - Urinary Tract infection, pneumonia, Deep vein Thrombosis (This information will be elicited at the follow-up time, based on recall. All subjects will be asked to bring documents related to any hospital admissions in the period following discharge )
1, 3, 6, 9 and 12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Aga Khan University

Investigadores

  • Investigador principal: Dr Ayeesha K Kamal, MBBS, Aga Khan University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2014

Conclusão Primária (Real)

1 de maio de 2016

Conclusão do estudo (Real)

1 de junho de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

24 de julho de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de julho de 2014

Primeira postagem (Estimativa)

29 de julho de 2014

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

8 de agosto de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de agosto de 2016

Última verificação

1 de agosto de 2016

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • URC132001MED

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