Medication AdherenceNCT04577157
mHealth App Intervention to Improve Medication Adherence
A study testing mHealth using"WhatsApp" multifaceted educational and reminder module intervention to improve adherence in people with Medication Adherence and Adherence, Treatment, run by Universiti Putra Malaysia at 1 site in Pakistan.
Trial summary
It is a parallel-design, two-arm, randomized controlled trial designed to assess the effectiveness of mHealth application using 7- items, multifaceted educational and reminder module intervention( written message, voice message, multimedia picture, Graphic based Messages(GBM), video, hypertension at a glance, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Adherence, Treatment
- What is being tested?
- mHealth using"WhatsApp" multifaceted educational and reminder module intervention to improve adherence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Jan 2021to 30 Nov 2021
- 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
- Participants with age more than 18 years
- Patients diagnosed with essential hypertension and registered in the cardiology and medical Outpatient Departments (OPDs) of three tertiary care hospitals of Lahore for the last one month.
- Participants on antihypertensive medication
- Only one member from one family.
- Participants have a mobile phone and have "Whatsapp" application installed on their cell phones
- Participants who can operate a mobile phone and can read and send a message on "Whatsapp".
Who cannot join
- Participants with planned travel within two months with no mobile signals.
- Participants with a history of malignancy and require medication adjustment.
- Participants with any planned procedure (during the study period) demand immediate medication changes like CABG, PCI, or CEA (Carotid Endarterectomy)
- Participants who are suffering from dementia, depression (self-reporting)
- Participants with blood-pressure measurement of >220/>120 mmHg (symptoms of a hypertensive emergency)
- Participants who are pregnant (self-reporting)
- Participants who are in their lactation period
- Participants within 3 months postpartum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of mHealth Intervention Using Multifaceted Educational and Reminder Module Intervention to Improve Medication Adherence and Treatment Outcome Among Hypertensive Patients in Lahore, Pakistan: a Randomized Controlled Trial
It is a parallel-design, two-arm, randomized controlled trial designed to assess the effectiveness of mHealth application using 7- items, multifaceted educational and reminder module intervention( written message, voice message, multimedia picture, Graphic based Messages(GBM), video, hypertension at a glance, and doctor support) to improve adherence to medication in hypertensive patients and clinical outcome systolic blood pressure in Lahore, Pakistan. Cost-effectiveness of this study will also be done.
Read the detailed description
Hypertension is indeed a significant public health concern in Pakistan. Hypertension drastically affects 18.9% of adolescents of age greater than 15 and 33% of adults of age above 45. Uncontrolled blood pressure (BP) is a leading risk factor for major hypertensive complications. In Pakistan, suboptimal adherence to medication remains a stumbling block to the success of antihypertensive treatment. A majority of the population in Pakistan on treatment is found to be non-adherent. mHealth is quite an apt tool positioned to counter these challenges of poor adherence in resource limit settings like Pakistan. What is available is too little to establish any causal relationship. The aim of this study is to assess the effectiveness of mHealth intervention by using a reminder module in improving patient medication adherence in hypertensive patients. The intervention was designed to improve the hypertension-related adherence in participants in the intervention group. The module will be developed and undergone via the process of consultations from a group of experts. These will include professors of epidemiology, one expert in behavioral intervention, two professors of health education, and one cardiologist specialist in hypertension management. For the intervention group, a "multifaceted educational reminder module" will be developed and delivered through "WhatsApp" (written message, voice message, and Graphic-based Reminder (GBR)) by an Information and Technology (IT) facilitator. This will be included daily notes for medication reminders, voice messages,s and Graphic-based Reminders (GBR), Twice-weekly Graphic based Messages(GBM), Lifestyle changing video, hypertension at a glance, and doctor support in addition to the standard care (as per being practiced routinely in the hospitals). WhatsApp is used in this study because of its feature of ticks, which turns out to blue after seeing the message and it is an indication to the sender if the receiver has seen the message, so, the participants no longer need to respond to calls or messages. If the intervention is found effective, it can help in developing educational guidelines for patients to improve their medication adherence and reduce related complications at the same time. This study will give a new line of research for coming researchers in the long run. Moreover, its cost-effectiveness will be assessed to predict one dollar bring about improvement per mmHg.
- Conditions
- Medication Adherence, Adherence, Treatment
- Being tested
- mHealth using"WhatsApp" multifaceted educational and reminder module intervention to improve adherence
- Medical subject headings
- Medication Adherence, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth using"WhatsApp" multifaceted educational and reminder module intervention to improve adherenceBehavioural
Also called Mobile health intervention, reminder module intervention,
This multifaceted educational and reminder module is named "Health@click". The content of the reminder module has been made based on "The Health Belief Model and self-determination theory.
- Daily notes for medication reminders,
- Daily a voice message with the same content will be delivered.
- Daily Graphics-based Reminder (GBR).
- Twice-weekly Graphics-based Messages (GBM) according to Health believe model and Self-determination theory constituents.
- Once-weekly lifestyle advice through video
- Hypertension at a glance, complete information will be provided(Optional)
- 24/7 help provision service will be given to the participants. A qualified doctor will be there to provide this educational support. Support will be including the dose of medicine, frequency, mode of action, effects of medicine on current illness, side effects, and interaction with different foods (Optional).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | The participants in the intervention group will receive Health@click (seven-item multifaceted educational and reminder module) through "WhatsApp". This will be included daily notes for medication reminders, voice messages, Graphics-based Reminders (GBR), Twice-weekly Graphics-based Messages (GBM), and once-weekly lifestyle advice through video in addition to standard care (as being practiced routinely in the hospitals). Besides this, a 24/7 help provision service will be given to the participants. A qualified doctor will be there to provide this educational support. Support will be including the dose of medicine, frequency, mode of action, effects of medicine on current illness, side effects and interaction with different foods, and psychological support to the participants who feel the need. Receives: Behavioral: mHealth using"WhatsApp" multifaceted educational and reminder module intervention to improve adherence |
| Control Arm | No intervention | Participants in the control group will receive no intervention except in standard care (as per being practiced routinely in the hospitals). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to medication (Medication Adherence Score)- Self Reported Scale
The primary outcome is (change) medication adherence to antihypertensive treatment (AHT) at 6 months. This will be assessed by self-reporting using a Standardized questionnaire, Self-efficacy for Appropriate Medication Adherence Scale (SEAMS) at 0, 3, and 6 months. It is a 13-item scale with a three-point response questionnaire, with (1 _ not confident, 2 _ somewhat confident and 3 _ very confident). The potential score for the 13-item scale ranged from 13 to 39. Higher scores indicated higher levels of self-efficacy for medication adherence and vice versa. Besides SEAMS, adherence rates will be also be calculated by 'pills taken over a specific period of time, divided by pills prescribed for that specific period of time. The cut-off value of 80% is set. Less than 80% will be considered non-adherent while >80% will be adherent. It will be self-reporting.
Measured: 6- month from baseline
Change in systolic blood pressure
The secondary outcome is a change in systolic blood pressure (SBP) of participants at 6 months. This will be assessed on measuring blood pressure at the hospital by a blinded staff nurse at 0, 3, and 6 months at the hospital by a blinded staff nurse using the calibrated upper-arm electronic sphygmomanometer (OMRON HEM-7200, OMRON Corporation, Dalian) with standard guidelines.
Measured: 6- month from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start3 Jan 2021
- Primary completion6 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a parallel-design, intention-to-treat, two-arm, randomized controlled trial, six months of duration with intervention module intervention pre-test and post-test evaluations to assess the effectiveness of mHealth application using Multi-aid-package intervention(voice, written message, and multimedia picture) to improve adherence to medication in hypertensive patients in Lahore, Pakistan. Participants will be assigned to the two groups in a parallel fashion in a ratio of 1:1. The intervention group will be given a reminder module intervention and control group with standard care (as per being practiced routinely in the hospitals).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arshed Muhammad, Universiti Putra Malaysia
- Investigators
- Mehwish Kiran, MBBS, Study director, Doctors Hospital, LahoreArshed Muhammad, MBBS, Principal investigator, UPM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577157
- Sponsor's protocol ID
- DPUTRA
- Status last verified
- Mar 2022
- First submitted
- 24 May 2020
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamal 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 30571697Bobrow K, Farmer AJ, Springer D, Shanyinde M, Yu LM, Brennan T, Rayner B, Namane M, Steyn K, Tarassenko L, Levitt N. Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (SMS-Text Adherence Support [StAR]): A Single-Blind, Randomized Trial. Circulation. 2016 Feb 9;133(6):592-600. doi: 10.1161/CIRCULATIONAHA.115.017530. Epub 2016 Jan 14.
PubMed 26769742Fang R, Li X. Electronic messaging support service programs improve adherence to lipid-lowering therapy among outpatients with coronary artery disease: an exploratory randomised control study. J Clin Nurs. 2016 Mar;25(5-6):664-71. doi: 10.1111/jocn.12988. Epub 2015 Nov 1.
PubMed 26522838Kamal 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 26486857Park LG, Howie-Esquivel J, Chung ML, Dracup K. A text messaging intervention to promote medication adherence for patients with coronary heart disease: a randomized controlled trial. Patient Educ Couns. 2014 Feb;94(2):261-8. doi: 10.1016/j.pec.2013.10.027. Epub 2013 Nov 18.
PubMed 24321403Vollmer WM, Owen-Smith AA, Tom JO, Laws R, Ditmer DG, Smith DH, Waterbury AC, Schneider JL, Yonehara CH, Williams A, Vupputuri S, Rand CS. Improving adherence to cardiovascular disease medications with information technology. Am J Manag Care. 2014 Nov;20(11 Spec No. 17):SP502-10.
PubMed 25811824Wald DS, Bestwick JP, Raiman L, Brendell R, Wald NJ. Randomised trial of text messaging on adherence to cardiovascular preventive treatment (INTERACT trial). PLoS One. 2014 Dec 5;9(12):e114268. doi: 10.1371/journal.pone.0114268. eCollection 2014.
PubMed 25479285WHO | The Declaration of Helsinki and public health. (n.d.). WHO; World Health Organization. Retrieved April 11, 2020, from https://www.who.int/bulletin/volumes/86/8/08-050955/en
Ni Z, Liu C, Wu B, Yang Q, Douglas C, Shaw RJ. An mHealth intervention to improve medication adherence among patients with coronary heart disease in China: Development of an intervention. Int J Nurs Sci. 2018 Sep 8;5(4):322-330. doi: 10.1016/j.ijnss.2018.09.003. eCollection 2018 Oct 10.
PubMed 31406843Gandapur Y, Kianoush S, Kelli HM, Misra S, Urrea B, Blaha MJ, Graham G, Marvel FA, Martin SS. The role of mHealth for improving medication adherence in patients with cardiovascular disease: a systematic review. Eur Heart J Qual Care Clin Outcomes. 2016 Oct 1;2(4):237-244. doi: 10.1093/ehjqcco/qcw018.
PubMed 29474713Jafar TH, Jafary FH, Jessani S, Chaturvedi N. Heart disease epidemic in Pakistan: women and men at equal risk. Am Heart J. 2005 Aug;150(2):221-6. doi: 10.1016/j.ahj.2004.09.025.
PubMed 16086922Lim CY, In J. Randomization in clinical studies. Korean J Anesthesiol. 2019 Jun;72(3):221-232. doi: 10.4097/kja.19049. Epub 2019 Apr 1.
PubMed 30929415Noordzij M, Tripepi G, Dekker FW, Zoccali C, Tanck MW, Jager KJ. Sample size calculations: basic principles and common pitfalls. Nephrol Dial Transplant. 2010 May;25(5):1388-93. doi: 10.1093/ndt/gfp732. Epub 2010 Jan 12.
PubMed 20067907Pednekar PP, Agh T, Malmenas M, Raval AD, Bennett BM, Borah BJ, Hutchins DS, Manias E, Williams AF, Hiligsmann M, Turcu-Stiolica A, Zeber JE, Abrahamyan L, Bunz TJ, Peterson AM. Methods for Measuring Multiple Medication Adherence: A Systematic Review-Report of the ISPOR Medication Adherence and Persistence Special Interest Group. Value Health. 2019 Feb;22(2):139-156. doi: 10.1016/j.jval.2018.08.006. Epub 2018 Oct 25.
PubMed 30711058Roberts C, Torgerson D. Randomisation methods in controlled trials. BMJ. 1998 Nov 7;317(7168):1301. doi: 10.1136/bmj.317.7168.1301. No abstract available.
PubMed 9804722
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of mHealth Intervention Using Multifaceted Educational and Reminder Module Intervention to Improve Medication Adherence and Treatment Outcome Among Hypertensive Patients in Lahore, Pakistan: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04577157
- Acronym / sponsor ID
- DPUTRA
- Conditions
- Medication Adherence, Adherence, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 6 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 6 Oct 2020 (actual)
- 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.
It is a parallel-design, two-arm, randomized controlled trial designed to assess the effectiveness of mHealth application using 7- items, multifaceted educational and reminder module intervention( written message, voice message, multimedia picture, Graphic based Messages(GBM), video, hypertension at a glance, and doctor support) to improve adherence to medication in hypertensive patients and clinical outcome systolic blood pressure in Lahore, Pakistan. Cost-effectiveness of this study will also be done.
Detailed description
Hypertension is indeed a significant public health concern in Pakistan. Hypertension drastically affects 18.9% of adolescents of age greater than 15 and 33% of adults of age above 45. Uncontrolled blood pressure (BP) is a leading risk factor for major hypertensive complications. In Pakistan, suboptimal adherence to medication remains a stumbling block to the success of antihypertensive treatment. A majority of the population in Pakistan on treatment is found to be non-adherent. mHealth is quite an apt tool positioned to counter these challenges of poor adherence in resource limit settings like Pakistan. What is available is too little to establish any causal relationship. The aim of this study is to assess the effectiveness of mHealth intervention by using a reminder module in improving patient medication adherence in hypertensive patients. The intervention was designed to improve the hypertension-related adherence in participants in the intervention group. The module will be developed and undergone via the process of consultations from a group of experts. These will include professors of epidemiology, one expert in behavioral intervention, two professors of health education, and one cardiologist specialist in hypertension management. For the intervention group, a "multifaceted educational reminder module" will be developed and delivered through "WhatsApp" (written message, voice message, and Graphic-based Reminder (GBR)) by an Information and Technology (IT) facilitator. This will be included daily notes for medication reminders, voice messages,s and Graphic-based Reminders (GBR), Twice-weekly Graphic based Messages(GBM), Lifestyle changing video, hypertension at a glance, and doctor support in addition to the standard care (as per being practiced routinely in the hospitals). WhatsApp is used in this study because of its feature of ticks, which turns out to blue after seeing the message and it is an indication to the sender if the receiver has seen the message, so, the participants no longer need to respond to calls or messages. If the intervention is found effective, it can help in developing educational guidelines for patients to improve their medication adherence and reduce related complications at the same time. This study will give a new line of research for coming researchers in the long run. Moreover, its cost-effectiveness will be assessed to predict one dollar bring about improvement per mmHg.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- It is a parallel-design, intention-to-treat, two-arm, randomized controlled trial, six months of duration with intervention module intervention pre-test and post-test evaluations to assess the effectiveness of mHealth application using Multi-aid-package intervention(voice, written message, and multimedia picture) to improve adherence to medication in hypertensive patients in Lahore, Pakistan. Participants will be assigned to the two groups in a parallel fashion in a ratio of 1:1. The intervention group will be given a reminder module intervention and control group with standard care (as per being practiced routinely in the hospitals).
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: mHealth using"WhatsApp" multifaceted educational and reminder module intervention to improve adherenceThe participants in the intervention group will receive Health@click (seven-item multifaceted educational and reminder module) through "WhatsApp". This will be included daily notes for medication reminders, voice messages, Graphics-based Reminders (GBR), Twice-weekly Graphics-based Messages (GBM), and once-weekly lifestyle advice through video in addition to standard care (as being practiced routinely in the hospitals). Besides this, a 24/7 help provision service will be given to the participants. A qualified doctor will be there to provide this educational support. Support will be including the dose of medicine, frequency, mode of action, effects of medicine on current illness, side effects and interaction with different foods, and psychological support to the participants who feel the need. |
| Control Arm | No intervention | –Participants in the control group will receive no intervention except in standard care (as per being practiced routinely in the hospitals). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants with age more than 18 years
- Patients diagnosed with essential hypertension and registered in the cardiology and medical Outpatient Departments (OPDs) of three tertiary care hospitals of Lahore for the last one month.
- Participants on antihypertensive medication
- Only one member from one family.
- Participants have a mobile phone and have "Whatsapp" application installed on their cell phones
Key exclusion criteria (8 listed)
- Participants with planned travel within two months with no mobile signals.
- Participants with a history of malignancy and require medication adjustment.
- Participants with any planned procedure (during the study period) demand immediate medication changes like CABG, PCI, or CEA (Carotid Endarterectomy)
- Participants who are suffering from dementia, depression (self-reporting)
- Participants with blood-pressure measurement of >220/>120 mmHg (symptoms of a hypertensive emergency)
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 |
|---|---|---|
| mHealth using"WhatsApp" multifaceted educational and reminder module intervention to improve adherenceAlso: Mobile health intervention, reminder module intervention,This multifaceted educational and reminder module is named "Health@click". The content of the reminder module has been made based on "The Health Belief Model and self-determination theory. 1. Daily notes for medication reminders, 2. Daily a voice message with the same content will be delivered. 3. Daily Graphics-based Reminder (GBR). 4. Twice-weekly Graphics-based Messages (GBM) according to Health believe model and Self-determination theory constituents. 5. Once-weekly lifestyle advice through video 6. Hypertension at a glance, complete information will be provided(Optional) 7. 24/7 help provision service will be given to the participants. A qualified doctor will be there to provide this educational support. Support will be including the dose of medicine, frequency, mode of action, effects of medicine on current illness, side effects, and interaction with different foods (Optional). | Behavioural | Intervention Arm |
Primary outcome
Adherence to medication (Medication Adherence Score)- Self Reported Scale
Time frame: 6- month from baseline
The primary outcome is (change) medication adherence to antihypertensive treatment (AHT) at 6 months. This will be assessed by self-reporting using a Standardized questionnaire, Self-efficacy for Appropriate Medication Adherence Scale (SEAMS) at 0, 3, and 6 months. It is a 13-item scale with a three-point response questionnaire, with (1 _ not confident, 2 _ somewhat confident and 3 _ very confident). The potential score for the 13-item scale ranged from 13 to 39. Higher scores indicated higher levels of self-efficacy for medication adherence and vice versa. Besides SEAMS, adherence rates will be also be calculated by 'pills taken over a specific period of time, divided by pills prescribed for that specific period of time. The cut-off value of 80% is set. Less than 80% will be considered non-adherent while >80% will be adherent. It will be self-reporting.
Change in systolic blood pressure
Time frame: 6- month from baseline
The secondary outcome is a change in systolic blood pressure (SBP) of participants at 6 months. This will be assessed on measuring blood pressure at the hospital by a blinded staff nurse at 0, 3, and 6 months at the hospital by a blinded staff nurse using the calibrated upper-arm electronic sphygmomanometer (OMRON HEM-7200, OMRON Corporation, Dalian) with standard guidelines.
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 17 Mar 2022.
- Background: 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.
- Background: PubMed 26769742Bobrow K, Farmer AJ, Springer D, Shanyinde M, Yu LM, Brennan T, Rayner B, Namane M, Steyn K, Tarassenko L, Levitt N. Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (SMS-Text Adherence Support [StAR]): A Single-Blind, Randomized Trial. Circulation. 2016 Feb 9;133(6):592-600. doi: 10.1161/CIRCULATIONAHA.115.017530. Epub 2016 Jan 14.
- Background: PubMed 26522838Fang R, Li X. Electronic messaging support service programs improve adherence to lipid-lowering therapy among outpatients with coronary artery disease: an exploratory randomised control study. J Clin Nurs. 2016 Mar;25(5-6):664-71. doi: 10.1111/jocn.12988. Epub 2015 Nov 1.
- Background: 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.
- Background: PubMed 24321403Park LG, Howie-Esquivel J, Chung ML, Dracup K. A text messaging intervention to promote medication adherence for patients with coronary heart disease: a randomized controlled trial. Patient Educ Couns. 2014 Feb;94(2):261-8. doi: 10.1016/j.pec.2013.10.027. Epub 2013 Nov 18.
- Background: PubMed 25811824Vollmer WM, Owen-Smith AA, Tom JO, Laws R, Ditmer DG, Smith DH, Waterbury AC, Schneider JL, Yonehara CH, Williams A, Vupputuri S, Rand CS. Improving adherence to cardiovascular disease medications with information technology. Am J Manag Care. 2014 Nov;20(11 Spec No. 17):SP502-10.
- Background: PubMed 25479285Wald DS, Bestwick JP, Raiman L, Brendell R, Wald NJ. Randomised trial of text messaging on adherence to cardiovascular preventive treatment (INTERACT trial). PLoS One. 2014 Dec 5;9(12):e114268. doi: 10.1371/journal.pone.0114268. eCollection 2014.
- BackgroundWHO | The Declaration of Helsinki and public health. (n.d.). WHO; World Health Organization. Retrieved April 11, 2020, from https://www.who.int/bulletin/volumes/86/8/08-050955/en
- Background: PubMed 31406843Ni Z, Liu C, Wu B, Yang Q, Douglas C, Shaw RJ. An mHealth intervention to improve medication adherence among patients with coronary heart disease in China: Development of an intervention. Int J Nurs Sci. 2018 Sep 8;5(4):322-330. doi: 10.1016/j.ijnss.2018.09.003. eCollection 2018 Oct 10.
- Background: PubMed 29474713Gandapur Y, Kianoush S, Kelli HM, Misra S, Urrea B, Blaha MJ, Graham G, Marvel FA, Martin SS. The role of mHealth for improving medication adherence in patients with cardiovascular disease: a systematic review. Eur Heart J Qual Care Clin Outcomes. 2016 Oct 1;2(4):237-244. doi: 10.1093/ehjqcco/qcw018.
- Background: PubMed 16086922Jafar TH, Jafary FH, Jessani S, Chaturvedi N. Heart disease epidemic in Pakistan: women and men at equal risk. Am Heart J. 2005 Aug;150(2):221-6. doi: 10.1016/j.ahj.2004.09.025.
- Background: PubMed 30929415Lim CY, In J. Randomization in clinical studies. Korean J Anesthesiol. 2019 Jun;72(3):221-232. doi: 10.4097/kja.19049. Epub 2019 Apr 1.
- Individual participant dataSharing planned: No
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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.
Mehwish Kiran, MBBS study director
Doctors Hospital, Lahore
Arshed Muhammad, MBBS principal investigator
UPM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth using"WhatsApp" multifaceted educational and reminder module intervention to improve adherence in people with Medication Adherence and Adherence, Treatment, run by Universiti Putra Malaysia 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 6 inclusion and 8 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 17 Mar 2022. 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?
Adherence to medication (Medication Adherence Score)- Self Reported Scale (time frame: 6- month from baseline). The study lists 2 primary outcomes in all. 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 NCT04577157, which also lists 19 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 17 Mar 2022.