跳至主要内容
临床试验/NCT02354040
NCT02354040已完成不适用

Using a Tailored Health Information Technology Driven Intervention to Improve Health Literacy and Medication Adherence in a Pakistani Population With Vascular Disease

Aga Khan University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Medication Adherence

研究概览

简要总结

Although most patients admitted with acute coronary syndrome or acute ischemic stroke in South Asian countries receive these evidence-based treatments, their overall continuation in the outpatient phase of care remains low. Patient from Pakistan are uniquely challenged in this respect because the overall literacy rates remain one of the lowest in Pakistan among South Asian Countries. In addition, a great majority of Pakistani patients often do not understand or follow health prescriptions (which are still written in English). Additionally, due to an unregulated health industry, they frequently take multiple opinions and prescriptions from different physicians. The investigators propose to develop a "talking prescription" for patients with stroke or myocardial infarction for secondary prevention. This will enable them to understand their medications better, improve health literacy and adherence. This is an IT enabled health literacy intervention. Physicians will prescribe statin and/or antiplatelet to the selected patients and enter the necessary details on an Optical Mark Recognition (OMR) sheet.Patients will be assigned to either of the 2 arms--either regular care or talking prescriptions. Follow-up will be done at 3 months post recruitment for behavioral knowledge assessment and adherence assessment.

详细描述

Physicians seeing patients in the outpatient clinics will write patient's statin and/or antiplatelet prescription and the patient's cell phone numbers on an Optical Mark Recognition (OMR) sheet. The sheet will also have dosage, route, frequency and durations options for respective medications. The physician will color the appropriate specification for a medication instead of writing the prescription by hand. Statin medications include lovastatin, fluvastatin, simvastatin, atorvastatin, pravastatin, rosuvastatin or pitavastatin. Antiplatelet medications include aspirin, clopidogrel, aspirin plus dipyridamole, cilostazol and prasugrel.

The unit receptionist would then scan the prescription sheet and upload the scanned copy to the database server.

Software in the server will analyze the prescription and generate the following outputs for each medication:

Output 1 (basic drug prescription information) (Option 1): Name of the medication, dosage, route, frequency, number of days, any special instruction, and Short Message Service (SMS) and Interactive Voice Response (IVR) code.

Output 2 (detailed drug information):

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Adult Men and Women ,18 years old
  • Use of anti-platelets and statins both.
  • Ischemic Stroke or CAD which is stable and outpatient based
  • Own Cell Phone
  • Can read local language,hear Cell phone,See a short text message
  • Willing to Give Written Informed Consent
  • Consent to follow up
  • Stroke and CAD are stable specifically, not requiring medical procedures that would necessitate frequent interruptions in medications.
  • Modified Rankin Score (MRS) Disability score should be less than 3.

排除标准

  • No Ischemic Stroke or CAD
  • Ischemic Stroke and CAD are unstable e.g. Unstable Angina, Acute MI, Need for CABG, Need for CEA, Need to rapidly adjust medication and inpatient care
  • Biological impairment in reading or responding to short text messages such as (but not limited to) loss of vision, visual field cuts, aphasia.
  • Diagnosed organ dysfunction or malignancy requiring stopping or adjustment of medications
  • Plans to travel outside the country inside the two months following enrollment
  • Known allergy or adverse reaction.
  • Absolute or relative contraindication to antiplatelet or statin e.g chronic liver disease, myopathy, Thrombotic Thrombocytopenic Purpura, GI bleed , Active Gastritis

研究组 & 干预措施

Talking Rx

Experimental

Assigned to receive Health Literacy and Reminder Updates via the IT based intervention Talking Rx, in addition to Usual Care for patients in the intervention group. The physician written prescription for anti-platelet and statin will be transferred on an OMR sheet and will be scanned. The information on the prescription (dose, name of the medication, duration, route or any other special instruction) will be sent to the patients via a text and a voice SMS (in Urdu language). The patients also receive an individualized code that helps them request for repeated reminders for their medication timings. However, a weekly medication reminder SMS will be sent to the patients in the intervention arm.

干预措施: Talking Rx (Behavioral)

Usual Care, Prescriptions and Counselling

No Intervention

Assigned to receive a standard prescription and Counselling only, there are no cointerventions in this group

结局指标

主要结局

Medication Adherence

时间窗: 3 Months

Morisky Medication Adherence Self Reported Scale

次要结局

  • Health Literacy(3 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Ayeesha Kamran Kamal

Ayeesha Kamran Kamal

Aga Khan University

研究点 (1)

Loading locations...

相似试验