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临床试验/NCT04738669
NCT04738669Unknown不适用

Effectiveness of Mhealth and Teach-back Methods in Readmissions Reduction in Prime Minister's National Health Programme - A Feasibility Randomized Controlled Trial

Health Services Academy, Islamabad, Pakistan2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
270
试验地点
2
主要终点
Readmission within 30 days post discharge

研究概览

简要总结

The Study is a feasibility randomized controlled trial aiming to assess the feasibility of mHealth (voice call and SMS) and teach-back interventions on reducing the 30 days readmission rate in the patients enrolled in the Sehat Sahulat Programme (Prime Minister National Health Programme(PMNHP)).

The prime objective of this study was to generate a proof of concept for the conduct of a definitive trial for the reduction in readmissions in PMNHP.

A feasibility randomized controlled trial study consisted of three arms i.e intervention 1 (telephonic contact and text messages), intervention 2 (teach-back method) and control is planned in program beneficiaries of Islamabad, Pakistan.

The trial is being carried out in the three hospitals of Islamabad and patients are being recruited as per the inclusion and exclusion criteria.

详细描述

Interventional Description of intervention(s) / exposure The study will comprise of three phases Phase I = Preparation Phase II= Implementation and monitoring Phase III = Evaluation Phase I (Preparation) i. Permissions

  • Ethical approval from Institutional review Board of Health Services Academy Islamabad
  • Permission from PMNHP to carry out a feasibility study
  • Written consent from doctors and nurses to be enrolled in the teach-back process
  • Informed verbal consent from all the selected patients to be enrolled in the PMNHP ii. Situation analysis The cross-sectional study will be conducted at the start of study prior to intervention to provide baseline data on selected variables. The baseline data will include sociodemographic status, diagnosis, comorbidities, length of stay in the hospital for the index admission.

Phase II (Implementation) i) Team building This step shall include recruiting educated individuals for the survey. For this purpose selected PMNHP staff will be recruited for telephonic contact with the patients.

Researcher himself will brief and orient the team on background and objectives, the usefulness of the study and data recording and medication adherence scale to be used in the study, in a one day workshop comprising of one session of 3 hours.

ii) Validation of the Urdu translation of Medication Adherence Questionaire (MAQ) In order to address the validity and reliability of the MAQ translation and back translations of the questionnaire will be carried out. The questionnaire will be pretested on 10 patients by the staff for adaptability in accordance with the WHO guidelines.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients > 30 years of age
  • Incident adult cases with index admission in PMNHP
  • Ischemic Heart disease, Myocardial Infarction, Hypertension, Diabetes Mellitus, Bronchial Asthma
  • Patients with a valid mobile number
  • Able to read the SMS in Urdu

排除标准

  • Serious mental illness such as schizophrenia,
  • Are unable to use a telephone
  • Are cognitively impaired during hospitalization as diagnosed by the consultant

结局指标

主要结局

Readmission within 30 days post discharge

时间窗: 30 Days post discharge

30 Days after discharge, participants were assessed for readmission

Readmission within 21 days post discharge

时间窗: 21 Days post discharge

21 Days after discharge, participants were assessed for readmission

Readmission within 7 days post discharge

时间窗: 7 days post discharge.

7 Days after discharge, participants were assessed for readmission.

Readmission within 14 days post discharge

时间窗: 14 days post discharge.

14 Days after discharge, participants were assessed for readmission.

次要结局

未报告次要终点

研究者

发起方
Health Services Academy, Islamabad, Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Syed Fawad Mashhadi

PhD Fellow

Health Services Academy, Islamabad, Pakistan

研究点 (2)

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