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In Pakistan, poor medication adherence is a key operational factor in the prevalence of uncontrolled hypertension. Mobile phone treatments based on technology are at the forefront and are a reasonably low-cost strategy for combating the latest health concerns associated with poor adherence. On the other hand, conservative approaches to counseling are also found effective. This study will look at how a mHealth-based strategy and an educational-led peer counseling intervention can help hypertensive patients with coronary artery disease lower their systolic blood pressure.
In Pakistan, hypertension is a serious public health concern. Hypertension affects 18.9% of teenagers over the age of 15 and 33% of adults over the age of 45; however, only around 3% of hypertensive individuals have their blood pressure regulated to 140/90 mm Hg or lower. The majority of hypertensive patients are found to have blood pressure that is out of control. The majority of those undergoing therapies were judged to be non-compliant. According to the study, adherence to cardiac medications ranged from 27 to 77 percent, while adherence to stroke medications was around 68 percent. According to a recent study, 37.7% of patients did not take their antihypertensive medication as advised.
Interventions to help hypertensive patients in controlling blood pressure show potential to alter their behavior and lead to better outcomes, but delivering them at a cheap cost is difficult. Although evidence is scarce, several trials examining clinical interventions utilizing conventional health education support while others employing a mobile health strategy, both showed significant results. For a low-resource country, we built cost-effective models that are integrated with clinical care for patients with hypertension. The goal of this trial is to assess the effectiveness of mHealth intervention with clinical educational support and educational support with peer counseling to improve blood pressure control in hypertensive patients when compared to standard care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care arm | No Intervention | The first group will be on standard care as usually being practiced in hospitals. | |
| Ed-counseling arm | Active Comparator | The second group will receive monthly educational support ( booklets) with peer counseling sessions in addition to standard care. |
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| mHealth | Active Comparator | The third group will receive daily written and voice reminders, and once weekly an education-led video in addition to standard care. |
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| Combined arm | Active Comparator | The fourth group will receive educational support (booklets)and counseling sessions every month, daily written and voice reminders, and once weekly an education-led video in addition to standard care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational support with peer counseling | Behavioral | This group will receive peer counseling therapy sessions will be led by doctors who specialize in hypertension. Patients and their families will be the focus of the sessions. Face-to-face sessions will take roughly 25-30 minutes. Patients will receive spoken and written instructions based on their abilities during these sessions. The counseling sessions are geared toward overcoming both general and personal obstacles. The educational component will be delivered through smart booklets. Information on hypertension, blood pressure self-monitoring, and frequent systolic blood pressure (SBP) tests, as well as body weight and serum cholesterol values, are included in the instructional support. Food control, exercise therapy, and hypertension problems and their management will also be explored as non-pharmacological therapeutic approaches. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in systolic blood pressure (SBP) | The primary outcome is a change in systolic blood pressure (SBP) of participants at 0, 6, and 12 months. The blood pressure will be recorded by sphygmomanometer used was calibrated upper-arm electronic sphygmomanometer (OMRON HEM-7200, OMRON Corporation, Dalian). Two separate readings will be taken within 5 min, and the average measurement will be the final. If the difference between the two measurements will be more than 5mmHg, then a third recording will be done and the average is considered. | 12- month from baseline |
| Proportion of participants achieving blood pressure < 140/90 mmHg | The proportion of participants achieving the control blood pressure < 140/90 mmHg | 12- month from baseline |
| Proportion of participants attending scheduled clinic appointments | The proportion of participants attending scheduled clinic appointments | 12- month from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring quality of life | To measure the health-related quality of life at baseline, three-month, and 12-month post-intervention, EuroQol 5-Dimension- 3-level will be used. The European quality of life scale (EQ-5D-3L) has five dimensions and three levels. Each of the five dimensions comprising the EQ-5D descriptive system is divided into three levels of perceived problems: LEVEL 1: indicating no problem LEVEL 2: indicating some problems LEVEL 3: indicating extreme problems, 1 (perfect health), with higher scores indicating higher health utility. 2- On a 20 cm vertical visual analog scale, the EQ-VAS captures the patient's self-rated health, with two unique endpoints such as "Best imaginable health condition" for a score of 100 and "Worst imaginable health state" for a score of 0. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in medication adherence to antihypertensive treatment |
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Inclusion Criteria:
Exclusion Criteria:
Participants who suffer from some type of malignancy and require adjustment of drugs
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arshed MUHAMMAD, MBBS,MPH | Contact | +923337474464 | drarshedchaudhary@gmail.com | |
| Maaz Arif Muhammad, MBBS | Contact | 00923481816881 | maazarifbutt@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Arshed MUHAMMAD | UPM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Victoria Hospital | Bahawalpur | Punjab Province | 63100 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27863813 | Background | NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in blood pressure from 1975 to 2015: a pooled analysis of 1479 population-based measurement studies with 19.1 million participants. Lancet. 2017 Jan 7;389(10064):37-55. doi: 10.1016/S0140-6736(16)31919-5. Epub 2016 Nov 16. | |
| 12493255 | Background | Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002 Dec 14;360(9349):1903-13. doi: 10.1016/s0140-6736(02)11911-8. |
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It's a 12-month factorial design, intention-to-treat, four-arm, double-blinded, multicentre, pragmatic randomized controlled trial with an intervention to assess the efficacy of mHealth and education support with peer counseling to improve treatment adherence and lower systolic blood pressure in hypertensive patients in three teaching hospitals in Lahore, Pakistan.
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Double-blinded
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| mHealth intervention | Behavioral | This group will receive mHealth intervention will include daily written and voice messages, and once weekly an educational-led video. This intervention module will be delivered through "WhatsApp". |
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| mHealth intervention and Educational support with peer counseling | Behavioral | This group will receive both Educational support (Smart booklets) with peer counseling sessions on a monthly basis and mHealth intervention will include daily written and voice reminders, and once weekly an educational led video. |
|
| 12- month from baseline |
| 12- month from baseline |
| Sheikh Zayed Hospital Rahim Yar Khan | Rahim Yar Khan | Punjab Province | 64200 | Pakistan |
| Jinnah Hospital | Lahore | 54000 | Pakistan |
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| Punjab Institute of Cardiology | Lahore | 54000 | Pakistan |
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| Rehmatul-lil-Almeen Institute of Cardiology | Lahore | 54000 | Pakistan |
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| Sheikh Zayed, Hospital | Lahore | 54000 | Pakistan |
|
| Background | NIPS/Pakistan and ICF NI of PS-. Pakistan Demographic and Health Survey 2017-18. 2019 [cited 4 Jan 2021]. Available: https://dhsprogram.com/publications/publication-fr354-dhs-final-reports.cfm |
| 32021119 | Background | Mahmood S, Jalal Z, Hadi MA, Orooj H, Shah KU. Non-Adherence to Prescribed Antihypertensives in Primary, Secondary and Tertiary Healthcare Settings in Islamabad, Pakistan: A Cross-Sectional Study. Patient Prefer Adherence. 2020 Jan 14;14:73-85. doi: 10.2147/PPA.S235517. eCollection 2020. |
| 32432556 | Background | Zhai P, Hayat K, Ji W, Li Q, Shi L, Atif N, Xu S, Li P, Du Q, Fang Y. Efficacy of Text Messaging and Personal Consultation by Pharmacy Students Among Adults With Hypertension: Randomized Controlled Trial. J Med Internet Res. 2020 May 20;22(5):e16019. doi: 10.2196/16019. |
| 23295957 | Background | Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583. |
| 29377058 | Background | Bhide A, Shah PS, Acharya G. A simplified guide to randomized controlled trials. Acta Obstet Gynecol Scand. 2018 Apr;97(4):380-387. doi: 10.1111/aogs.13309. Epub 2018 Feb 27. |
| 18232619 | Background | Risser J, Jacobson TA, Kripalani S. Development and psychometric evaluation of the Self-efficacy for Appropriate Medication Use Scale (SEAMS) in low-literacy patients with chronic disease. J Nurs Meas. 2007;15(3):203-19. doi: 10.1891/106137407783095757. |
| 11021874 | Background | Strobl J, Cave E, Walley T. Data protection legislation: interpretation and barriers to research. BMJ. 2000 Oct 7;321(7265):890-2. doi: 10.1136/bmj.321.7265.890. No abstract available. |
| 24227870 | Background | Del Re AC, Maisel NC, Blodgett JC, Finney JW. Intention-to-treat analyses and missing data approaches in pharmacotherapy trials for alcohol use disorders. BMJ Open. 2013 Nov 12;3(11):e003464. doi: 10.1136/bmjopen-2013-003464. |
| 14633287 | Background | Montgomery AA, Peters TJ, Little P. Design, analysis and presentation of factorial randomised controlled trials. BMC Med Res Methodol. 2003 Nov 24;3:26. doi: 10.1186/1471-2288-3-26. |
| 22810445 | Background | Whelan DB, Dainty K, Chahal J. Efficient designs: factorial randomized trials. J Bone Joint Surg Am. 2012 Jul 18;94 Suppl 1:34-8. doi: 10.2106/JBJS.L.00243. |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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