A Factorial Approach to Improve Treatment Adherence and Systolic Blood Pressure

NCT05106790 | Unknown

• 1 other identifier: APUTRA
• Study Type: interventional
• Target: 1,440
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Treatment Adherence and Compliance

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Measuring quality of life

  12- month from baseline

Other Outcomes (1)

• Change in medication adherence to antihypertensive treatment

  12- month from baseline

Study Arms (4)

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.

Behavioral: Educational support with peer counseling

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.

Behavioral: mHealth intervention

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.

Behavioral: mHealth intervention and Educational support with peer counseling

Interventions

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.

Ed-counseling arm

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".

mHealth

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.

Combined arm

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with age 21 to 70 years
• 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

You may not qualify if:

• Participants who suffer from some type of malignancy and require adjustment of drugs
• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (6)

Victoria Hospital

Bahawalpur, Punjab Province, 63100, Pakistan

Location

Sheikh Zayed Hospital Rahim Yar Khan

Rahim Yar Khan, Punjab Province, 64200, Pakistan

Location

Jinnah Hospital

Lahore, 54000, Pakistan

Location

Punjab Institute of Cardiology

Lahore, 54000, Pakistan

Location

Rehmatul-lil-Almeen Institute of Cardiology

Lahore, 54000, Pakistan

Location

Sheikh Zayed, Hospital

Lahore, 54000, Pakistan

Location

Related Publications (12)

• 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.

  PMID: 27863813 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.

  PMID: 12493255 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

  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.

  PMID: 32021119 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.

  PMID: 32432556 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.

  PMID: 23295957 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.

  PMID: 29377058 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.

  PMID: 18232619 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.

  PMID: 11021874 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.

  PMID: 24227870 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.

  PMID: 14633287 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.

  PMID: 22810445 BACKGROUND

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Arshed MUHAMMAD

  UPM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arshed MUHAMMAD, MBBS,MPH

CONTACT

+923337474464; drarshedchaudhary@gmail.com

Maaz Arif Muhammad, MBBS

CONTACT

00923481816881; maazarifbutt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD studentship

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2021
• First Posted: November 4, 2021
• Study Start: July 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: September 15, 2023
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (6)