A Factorial Approach to Improve Treatment Adherence and Systolic Blood Pressure

Treatment Adherence and Compliance Clinical Trial

Official title:

Efficacy of mHealth and Education-led Peer Counseling of Patients With Hypertension and Coronary Artery Disease: a Double-blinded Pragmatic Randomized Control Trial With Factorial Design, Pakistan

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05106790
• Other study ID #: APUTRA
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: September 15, 2023

Study information

• Verified date: May 2022
• Source: Universiti Putra Malaysia
• Contact: Arshed MUHAMMAD, MBBS,MPH
• Phone: +923337474464
• Email: drarshedchaudhary[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1440
• Est. completion date: September 15, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Treatment Adherence and Compliance

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Pakistan	Victoria Hospital	Bahawalpur	Punjab
Pakistan	Jinnah Hospital	Lahore
Pakistan	Punjab Institute of Cardiology	Lahore
Pakistan	Rehmatul-lil-Almeen Institute of Cardiology	Lahore
Pakistan	Sheikh Zayed, Hospital	Lahore
Pakistan	Sheikh Zayed Hospital Rahim Yar Khan	Rahim Yar Khan	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Pakistan, 

References & Publications (12)

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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. — View Citation

Montgomery AA, Peters TJ, Little P. Design, analysis and presentation of factorial randomised controlled trials. BMC Med Res Methodol. 2003 Nov 24;3:26. — View Citation

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. Erratum in: Lancet. 2020 Sep 26;396(10255):886. — View Citation

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

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. — View Citation

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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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in medication adherence to antihypertensive treatment	The secondary outcome is the change in medication adherence to antihypertensive treatment. Using the "pills taken over a certain period, divided by pills prescribed for that specific period", the primary outcome will be measured.it will be self-reporting. A cut-off value of 80% has been established from previous literature. Non-adherents will make up less than 80% of the population, while adherents will make up more than 80%.; The SEAMS is a 13-item questionnaire that has three-point responses. The score for the 13-item scale ranges from 13 to 39. Higher scores show better levels of self-efficacy for medication adherence and vice versa.	12- month from baseline
Primary	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
Primary	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
Primary	Proportion of participants attending scheduled clinic appointments	The proportion of participants attending scheduled clinic appointments	12- month from baseline
Secondary	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.	12- month from baseline