Vascular DiseaseTalkingRxNCT02354040
Using a Tailored Health Information Technology Driven Intervention to Improve Health Literacy and Medication Adherence
A study testing Talking Rx in people with Vascular Disease and Cerebrovascular Disorders, run by Aga Khan University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Disease, Cerebrovascular Disorders, Ischemic Heart Disease
- What is being tested?
- Talking Rx
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using a Tailored Health Information Technology Driven Intervention to Improve Health Literacy and Medication Adherence in a Pakistani Population With Vascular Disease
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.
Read the 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.
- Conditions
- Vascular Disease, Cerebrovascular Disorders, Ischemic Heart Disease, Coronary Artery Disease
- Being tested
- Talking Rx
- Keywords
- Stroke, Myocardial Infarction, Adherence, Health Literacy, Implementation, Developing Country
- Medical subject headings
- Vascular Diseases, Cerebrovascular Disorders, Myocardial Ischemia, Coronary Artery Disease, Stroke, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talking RxBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Talking Rx |
| Usual Care, Prescriptions and Counselling | No intervention | Assigned to receive a standard prescription and Counselling only, there are no cointerventions in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
Morisky Medication Adherence Self Reported Scale
Measured: 3 Months
Secondary outcomes (1)
Health Literacy
Adapted and Modified TOFHLA Scale - Test of Health Literacy in Adults
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Responsible party
- Principal investigator, Dr. Ayeesha Kamran Kamal, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354040
- Sponsor's protocol ID
- 3165- MED-ERC_14
- Acronym
- TalkingRx
- Status last verified
- Dec 2017
- First submitted
- 29 Jan 2015
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
PubMed 34813082Kamal AK, Khalid W, Muqeet A, Jamil A, Farhat K, Gillani SRA, Zulfiqar M, Saif M, Muhammad AA, Zaidi F, Mustafa M, Gowani A, Sharif S, Bokhari SS, Tai J, Rahman N, Sultan FAT, Sayani S, Virani SS. Making prescriptions "talk" to stroke and heart attack survivors to improve adherence: Results of a randomized clinical trial (The Talking Rx Study). PLoS One. 2018 Dec 20;13(12):e0197671. doi: 10.1371/journal.pone.0197671. eCollection 2018.
PubMed 30571697Kamal AK, Muqeet A, Farhat K, Khalid W, Jamil A, Gowani A, Muhammad AA, Zaidi F, Khan D, Elahi T, Sharif S, Raz S, Zafar T, Bokhari SS, Rahman N, Sultan FA, Sayani S, Virani SS. Using a tailored health information technology- driven intervention to improve health literacy and medication adherence in a Pakistani population with vascular disease (Talking Rx) - study protocol for a randomized controlled trial. Trials. 2016 Mar 5;17(1):121. doi: 10.1186/s13063-016-1244-1.
PubMed 26944938
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Tailored Health Information Technology Driven Intervention to Improve Health Literacy and Medication Adherence in a Pakistani Population With Vascular Disease
- ClinicalTrials.gov ID
- NCT02354040
- Acronym / sponsor ID
- TalkingRx / 3165- MED-ERC_14
- Conditions
- Vascular Disease, Cerebrovascular Disorders, Ischemic Heart Disease, Coronary Artery Disease
- Keywords
- Stroke, Myocardial Infarction, Adherence, Health Literacy, Implementation, Developing Country
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Talking Rx | Experimental | Behavioral: Talking RxAssigned 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. |
| Usual Care, Prescriptions and Counselling | No intervention | –Assigned to receive a standard prescription and Counselling only, there are no cointerventions in this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talking RxFor 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. | Behavioural | Talking Rx |
Primary outcome
Medication Adherence
Time frame: 3 Months
Morisky Medication Adherence Self Reported Scale
1 secondary outcome
Health Literacy
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Derived from this study: PubMed 34813082Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
- Derived from this study: PubMed 30571697Kamal AK, Khalid W, Muqeet A, Jamil A, Farhat K, Gillani SRA, Zulfiqar M, Saif M, Muhammad AA, Zaidi F, Mustafa M, Gowani A, Sharif S, Bokhari SS, Tai J, Rahman N, Sultan FAT, Sayani S, Virani SS. Making prescriptions "talk" to stroke and heart attack survivors to improve adherence: Results of a randomized clinical trial (The Talking Rx Study). PLoS One. 2018 Dec 20;13(12):e0197671. doi: 10.1371/journal.pone.0197671. eCollection 2018.
- Derived from this study: PubMed 26944938Kamal AK, Muqeet A, Farhat K, Khalid W, Jamil A, Gowani A, Muhammad AA, Zaidi F, Khan D, Elahi T, Sharif S, Raz S, Zafar T, Bokhari SS, Rahman N, Sultan FA, Sayani S, Virani SS. Using a tailored health information technology- driven intervention to improve health literacy and medication adherence in a Pakistani population with vascular disease (Talking Rx) - study protocol for a randomized controlled trial. Trials. 2016 Mar 5;17(1):121. doi: 10.1186/s13063-016-1244-1.
Related trials for Vascular Disease
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Talking Rx in people with Vascular Disease and Cerebrovascular Disorders, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02354040, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.