A Factorial Approach to Improve Treatment Adherence and Systolic Blood Pressure
NCT ID: NCT05106790
Last Updated: 2022-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1440 participants
INTERVENTIONAL
2022-07-01
2023-09-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Standard care arm
The first group will be on standard care as usually being practiced in hospitals.
No interventions assigned to this group
Ed-counseling arm
The second group will receive monthly educational support ( booklets) with peer counseling sessions in addition to standard care.
Educational support with peer counseling
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.
mHealth
The third group will receive daily written and voice reminders, and once weekly an education-led video in addition to standard care.
mHealth intervention
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".
Combined arm
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.
mHealth intervention and Educational support with peer counseling
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.
Interventions
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Educational support with peer counseling
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.
mHealth intervention
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".
mHealth intervention and Educational support with peer counseling
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.
Eligibility Criteria
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Inclusion Criteria
* Participants who have been registered as hypertensive with comorbidity of coronary artery disease in the Outpatient Departments (OPDs) of one of the three public teaching hospitals in Lahore, for at least last one month
* Participants on antihypertensive drugs
* The participants with stable coronary artery disease who are treated in an outpatient setting
* Participants who are willing to sign a written informed consent form, must have a smartphone with the WhatsApp application installed and be able to read Urdu/English.
* Participants with smartphones and have internet access
Exclusion Criteria
* Participants with any biological condition that makes it difficult for them to read write, communicate or hear phone calls
* Participants in hypertensive emergency blood pressure \>220/120 mmHg
* Participants with pregnancy(self-reporting)
* Participants in their period of lactation
21 Years
70 Years
ALL
No
Sponsors
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Universiti Putra Malaysia
OTHER
Responsible Party
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Arshed Muhammad
PhD studentship
Principal Investigators
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Arshed MUHAMMAD
Role: PRINCIPAL_INVESTIGATOR
UPM
Locations
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Victoria Hospital
Bahawalpur, Punjab Province, Pakistan
Sheikh Zayed Hospital Rahim Yar Khan
Rahim Yar Khan, Punjab Province, Pakistan
Jinnah Hospital
Lahore, , Pakistan
Punjab Institute of Cardiology
Lahore, , Pakistan
Rehmatul-lil-Almeen Institute of Cardiology
Lahore, , Pakistan
Sheikh Zayed, Hospital
Lahore, , Pakistan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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APUTRA
Identifier Type: -
Identifier Source: org_study_id
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