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Using a Tailored Health Information Technology Driven Intervention to Improve Health Literacy and Medication Adherence (TalkingRx)

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ClinicalTrials.gov Identifier: NCT02354040
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
Dr. Ayeesha Kamran Kamal, Aga Khan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vascular Disease Cerebrovascular Disorders Ischemic Heart Disease Coronary Artery Disease Behavioral: Talking Rx Not Applicable

Detailed Description:

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):

Indication (Option 2), Contraindications and side/adverse effects (Option 3), and Drug-drug interactions and drug-food interactions (Option 4).

SMS software would then send a voice and text message to the patient's cell phone with Output 1. The voice message will be in Urdu. The prescription would be read to the patient through voice message in Urdu. The text message with Output 1 would be sent in Roman Urdu.

Output 1 will also generate a unique code for each patient. The patient will use this code, at any time of his/her convenience, to request for a repeated text or voice message for output 1 or to request for a repeated text or voice message for Output 2 (if the patient is interested in receiving detailed drug information). The patient would be able to receive both the outputs multiple times, on-demand.

Patient will also receive a weekly text message reminding them to take their statin and/or antiplatelet medication.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Using a Tailored Health Information Technology Driven Intervention to Improve Health Literacy and Medication Adherence in a Pakistani Population With Vascular Disease
Actual Study Start Date : April 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Literacy

Arm Intervention/treatment
Experimental: Talking Rx
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.
Behavioral: Talking Rx
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.

No Intervention: Usual Care, Prescriptions and Counselling
Assigned to receive a standard prescription and Counselling only, there are no cointerventions in this group



Primary Outcome Measures :
  1. Medication Adherence [ Time Frame: 3 Months ]
    Morisky Medication Adherence Self Reported Scale


Secondary Outcome Measures :
  1. Health Literacy [ Time Frame: 3 Months ]
    Adapted and Modified TOFHLA Scale - Test of Health Literacy in Adults



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354040


Locations
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Pakistan
Aga Khan University, Clinical Trial Unit
Karachi, Pakistan
Sponsors and Collaborators
Aga Khan University
Baylor College of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Ayeesha Kamran Kamal, Ayeesha Kamran Kamal, Aga Khan University
ClinicalTrials.gov Identifier: NCT02354040    
Other Study ID Numbers: 3165- MED-ERC_14
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Keywords provided by Dr. Ayeesha Kamran Kamal, Aga Khan University:
Stroke, Myocardial Infarction, Adherence, Health Literacy, Implementation, Developing Country
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases