Medication AdherenceNCT01986023
Improving Medication Adherence Through SMS (Short Messaging Service) in Adult Stroke Patients: a Randomised Controlled Behaviour Intervention Trial
A study testing SMS- Short Messaging Service in people with Medication Adherence and Stroke, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The impact of medications used for secondary stroke prevention relies heavily upon patient adherence. Adherence is defined as "the extent to which a person's behavior - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider." It is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Stroke
- What is being tested?
- SMS- Short Messaging Service
- 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
- Dec 2013to Jun 2014
- 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
- Adults > 18 years
- Diagnosed with stroke at least one month ago on neuroimaging (CT or MRI)
- Taking more than one drug for risk factor control
- Possessing a personal mobile phone
- Modified Rankin scores <3 (to exclude severely disabled persons)
- Able to operate sms
- Do not intend to travel outside the country in the next 2 months (because the followup period is 2 months and during this period mobile communication through sms is required)
- Give informed consent
Who cannot join
- Chronic Renal Failure (because such patients keep getting admitted often and also have several contraindications for therapy)
- Any known malignancy
- Enrolled in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled SMS Intervention For Improving Medication Adherence in Adult Stroke Patients
The impact of medications used for secondary stroke prevention relies heavily upon patient adherence. Adherence is defined as "the extent to which a person's behavior - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider." It is said that optimal adherence to medications may reduce the risk of a poor outcome by 26%.
The purpose of this study which is a non-pharmacologic behavioral study is to encourage adherence to medications in stroke survivors by tailored and specific SMS reminders. (Short Text Messages). These SMS reminders will support and assist stroke patients to take medications as prescribed and on time. We hypothesise that SMS will improve the adherence of patients to stroke medications by 2 points on the Morisky Medication Adherence Scale.
Read the detailed description
Stroke remains a major cause of death and disability globally, accounting for 46.6 million disability adjusted life-years (DALYs) worldwide. More than 85% of all stroke-related deaths occur in low- and middle-income (LMI) countries. In a study from our center in Pakistan, the all-cause mortality due to stroke was 12.9% in the first year. Vascular causes in general and recurrent stroke in particular accounted for the bulk of the mortality cases. Recurrence of a stroke in Pakistan is documented to be as high as 53% in the first year, as opposed to international rates of approximately 30% in the first month. Evidence based guidelines recommend risk factor control with antiplatelet agents, anti-hypertensive medications, lipid lowering drugs and appropriate anti-diabetic therapy to reduce the risk of stroke recurrence. When taken together, the combination of an antihypertensive, statin and antiplatelet agent can reduce total stroke risk by 80%.
However, the impact of drugs used for secondary stroke prevention relies heavily upon patient adherence. Adherence is defined as "the extent to which a person's behavior - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider." It is said that optimal adherence to medications may reduce the risk of a poor outcome by 26%.
The purpose of this study which is a non-pharmacologic behavioral study is to encourage adherence to medications in stroke survivors by tailored and specific SMS (Short Text Messages) reminders. These SMS reminders will support and assist stroke patients to take medications as prescribed and on time. We hypothesise that SMS will improve the adherence of patients to stroke medications by 2 points on the Morisky Medication Adherence Scale.
- Conditions
- Medication Adherence, Stroke
- Being tested
- SMS- Short Messaging Service
- Keywords
- Stroke, Medication Adherence, SMS, Randomised
- Medical subject headings
- Medication Adherence, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS- Short Messaging ServiceBehavioural
| Study group | Role | What they receive |
|---|---|---|
| SMS Short Message Service Arm plus Prescription | Experimental | Intervention is as follows: Drug reminder SMS will be sent to the participants in the intervention arm customised to their stroke prescription. These SMS will be interactive in a way that the participants will have to answer back if they have taken their medicine or not in a "Yes/No" format. Moreover behaviour change SMS will also be sent to the intervention arm twice weekly. In addition , Participants will be encouraged to take medication using a taxonomy of behavioral change intervention techniques. Receives: Behavioral: SMS- Short Messaging Service |
| Standard Prescriptions and Counselling | No intervention | The usual care arm will undergo standard treatment and counselling regarding their treatment and the education regarding their medication as per standard of care. They will receive a standard written prescription and no SMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence Score
Subjects will undergo measurement of their medication Adherence Scores after 2 months of follow up on the Morisky Medication Adherence Questionnaire
Measured: 2 months
Secondary outcomes (2)
Patient Satisfaction with Intervention
This is a self designed tool which will measure the level of patient satisfaction in the intervention arm with the SMS intervention
Measured: 2 months
Acceptability of m-Health intervention
This is a self designed tool which will measure the acceptability of m-Health intervention i.e. SMS among the participants in the intervention group
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ayeesha Kamran Kamal, Aga Khan University
- Investigators
- Ayeesha K Kamal, MBBS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986023
- Sponsor's protocol ID
- D43TW008660
- Status last verified
- Aug 2014
- First submitted
- 5 Nov 2013
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kamal AK, Shaikh Q, Pasha O, Azam I, Islam M, Memon AA, Rehman H, Akram MA, Affan M, Nazir S, Aziz S, Jan M, Andani A, Muqeet A, Ahmed B, Khoja S. A randomized controlled behavioral intervention trial to improve medication adherence in adult stroke patients with prescription tailored Short Messaging Service (SMS)-SMS4Stroke study. BMC Neurol. 2015 Oct 21;15:212. doi: 10.1186/s12883-015-0471-5.
PubMed 26486857Kamal AK, Shaikh QN, Pasha O, Azam I, Islam M, Memon AA, Rehman H, Affan M, Nazir S, Aziz S, Jan M, Andani A, Muqeet A, Ahmed B, Khoja S. Improving medication adherence in stroke patients through Short Text Messages (SMS4Stroke)-study protocol for a randomized, controlled trial. BMC Neurol. 2015 Aug 28;15:157. doi: 10.1186/s12883-015-0413-2.
PubMed 26311325
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled SMS Intervention For Improving Medication Adherence in Adult Stroke Patients
- ClinicalTrials.gov ID
- NCT01986023
- Acronym / sponsor ID
- D43TW008660
- Conditions
- Medication Adherence, Stroke
- Keywords
- Stroke, Medication Adherence, SMS, Randomised
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Nov 2013 (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.
The impact of medications used for secondary stroke prevention relies heavily upon patient adherence. Adherence is defined as "the extent to which a person's behavior - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider." It is said that optimal adherence to medications may reduce the risk of a poor outcome by 26%.
The purpose of this study which is a non-pharmacologic behavioral study is to encourage adherence to medications in stroke survivors by tailored and specific SMS reminders. (Short Text Messages). These SMS reminders will support and assist stroke patients to take medications as prescribed and on time. We hypothesise that SMS will improve the adherence of patients to stroke medications by 2 points on the Morisky Medication Adherence Scale.
Detailed description
Stroke remains a major cause of death and disability globally, accounting for 46.6 million disability adjusted life-years (DALYs) worldwide. More than 85% of all stroke-related deaths occur in low- and middle-income (LMI) countries. In a study from our center in Pakistan, the all-cause mortality due to stroke was 12.9% in the first year. Vascular causes in general and recurrent stroke in particular accounted for the bulk of the mortality cases. Recurrence of a stroke in Pakistan is documented to be as high as 53% in the first year, as opposed to international rates of approximately 30% in the first month. Evidence based guidelines recommend risk factor control with antiplatelet agents, anti-hypertensive medications, lipid lowering drugs and appropriate anti-diabetic therapy to reduce the risk of stroke recurrence. When taken together, the combination of an antihypertensive, statin and antiplatelet agent can reduce total stroke risk by 80%.
However, the impact of drugs used for secondary stroke prevention relies heavily upon patient adherence. Adherence is defined as "the extent to which a person's behavior - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider." It is said that optimal adherence to medications may reduce the risk of a poor outcome by 26%.
The purpose of this study which is a non-pharmacologic behavioral study is to encourage adherence to medications in stroke survivors by tailored and specific SMS (Short Text Messages) reminders. These SMS reminders will support and assist stroke patients to take medications as prescribed and on time. We hypothesise that SMS will improve the adherence of patients to stroke medications by 2 points on the Morisky Medication Adherence Scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS Short Message Service Arm plus Prescription | Experimental | Behavioral: SMS- Short Messaging ServiceIntervention is as follows: Drug reminder SMS will be sent to the participants in the intervention arm customised to their stroke prescription. These SMS will be interactive in a way that the participants will have to answer back if they have taken their medicine or not in a "Yes/No" format. Moreover behaviour change SMS will also be sent to the intervention arm twice weekly. In addition , Participants will be encouraged to take medication using a taxonomy of behavioral change intervention techniques. |
| Standard Prescriptions and Counselling | No intervention | –The usual care arm will undergo standard treatment and counselling regarding their treatment and the education regarding their medication as per standard of care. They will receive a standard written prescription and no SMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults > 18 years
- Diagnosed with stroke at least one month ago on neuroimaging (CT or MRI)
- Taking more than one drug for risk factor control
- Possessing a personal mobile phone
- Modified Rankin scores <3 (to exclude severely disabled persons)
Key exclusion criteria (3 listed)
- Chronic Renal Failure (because such patients keep getting admitted often and also have several contraindications for therapy)
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 |
|---|---|---|
| SMS- Short Messaging Service | Behavioural | SMS Short Message Service Arm plus Prescription |
Primary outcome
Medication Adherence Score
Time frame: 2 months
Subjects will undergo measurement of their medication Adherence Scores after 2 months of follow up on the Morisky Medication Adherence Questionnaire
2 secondary outcomes
Patient Satisfaction with Intervention
Time frame: 2 months
Acceptability of m-Health intervention
Time frame: 2 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 19 Aug 2014.
- Derived from this study: PubMed 26486857Kamal AK, Shaikh Q, Pasha O, Azam I, Islam M, Memon AA, Rehman H, Akram MA, Affan M, Nazir S, Aziz S, Jan M, Andani A, Muqeet A, Ahmed B, Khoja S. A randomized controlled behavioral intervention trial to improve medication adherence in adult stroke patients with prescription tailored Short Messaging Service (SMS)-SMS4Stroke study. BMC Neurol. 2015 Oct 21;15:212. doi: 10.1186/s12883-015-0471-5.
- Derived from this study: PubMed 26311325Kamal AK, Shaikh QN, Pasha O, Azam I, Islam M, Memon AA, Rehman H, Affan M, Nazir S, Aziz S, Jan M, Andani A, Muqeet A, Ahmed B, Khoja S. Improving medication adherence in stroke patients through Short Text Messages (SMS4Stroke)-study protocol for a randomized, controlled trial. BMC Neurol. 2015 Aug 28;15:157. doi: 10.1186/s12883-015-0413-2.
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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.
Ayeesha K Kamal, MBBS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS- Short Messaging Service in people with Medication Adherence and Stroke, 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 8 inclusion and 3 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 19 Aug 2014. 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 Score (time frame: 2 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 NCT01986023, which also lists 2 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 19 Aug 2014.