Condition category
Circulatory System
Date applied
11/02/2020
Date assigned
03/04/2020
Last edited
03/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Self-monitoring of blood pressure has the potential to engage patients, increase the accuracy of measurement, and improve management, and it has been endorsed by key professional organizations. However, little is known about how it is perceived and experienced by patients, and how information and counseling interventions can enhance its effects over time. This study is conducted in Lebanon where hypertension and overweight are prevalent and success in reducing hypertension has been limited. This project includes a situation analysis on the context of hypertension management, and a pilot study that assesses the feasibility and acceptability of an intervention built around self-monitoring of blood pressure and health education, and measures its effect on the management of hypertension in a sample of patients.

Who can participate?
Hypertensive patients recruited from physicians’ waiting rooms in two primary health care centers and a tertiary health care center in Beirut. Patients are eligible if they were Lebanese adults (18+) with a prior diagnosis of hypertension.

What does the study involve?
Participants are randomly allocated by the research team to either home self-monitoring of blood pressure with educational sessions, or the standard of care group. Face-to-face interviews are conducted with all participants at the start and 6 weeks later.

What are the possible benefits and risks of participating?
Participation in this study does not involve any physical risk or emotional risk to the patient beyond the risks of daily life. Participating in this study is beneficial to patients in the pilot intervention group, as it would lead to increased awareness of high blood pressure, its causes, management including the use of the self-monitoring blood pressure machines, and recommended lifestyle changes. Patients in the standard of care group would also benefit from added information and awareness, thanks to conversations in the course of the survey and receipt of educational materials. Because of the possibility that the provision of self-monitoring devices to patients may lead to anxiety regarding high blood pressure readings, the researchers provided information on how to deal with anxiety in this context and when to seek care.

Where is the study run from?
1. American University of Beirut Medical Center (Lebanon)
2. Howard Karagheusian Commemorative Corporation (Lebanon)
3. Amel Association (Lebanon)

When is the study starting and how long is it expected to run for?
April 2016 to April 2019

Who is funding the study?
Harvard Medical School Center for Global Health Delivery (Dubai)

Who is the main contact?
Dr Hala Ghattas
hg15@aub.edu.lb

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chaza Akik

ORCID ID

Contact details

Bliss Street
Beirut
1107
Lebanon
+961 (0)3410366
ca36@aub.edu.lb

Type

Scientific

Additional contact

Dr Hala Ghattas

ORCID ID

Contact details

Principal Investigator
Center for Research on Population and Health
Faculty of Health Sciences
American University of Beirut
Van Dyck Building
Room 338
Beirut
-
Lebanon
+961 (0)1 350000 ext: 4679
hg15@aub.edu.lb

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

FHS.HG.13/SBS-2017-0612

Study information

Scientific title

Engaging patients in managing hypertension: patient experience with self-monitoring of blood pressure

Acronym

Study hypothesis

Self-monitoring of blood pressure has the potential to engage patients, increase the accuracy of measurement, and improve management, and it has been endorsed by key professional organizations. The researchers sought to investigate how it is perceived and experienced by patients, and how information and counseling interventions can enhance its effects over time, specifically in Arab countries, where hypertension and overweight are prevalent and success in reducing hypertension has been limited.

This project includes:
1. A situation analysis on the context of hypertension management
2. A pilot study that assesses the feasibility and acceptability of an intervention built around self-monitoring of blood pressure and health education, and measures its effect on the management of hypertension in a sample of patients

Ethics approval

Approved 06/06/2018, 04/10/2018, American University of Beirut Institutional Review Board (PO Box 11-0236 (F15), Riad El Solh 1107 2020, Beirut, Lebanon; Tel: +961 (0)1 350000 ext: 5445; Email: irb@aub.edu.lb), ref: FHS.HG.13

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Hypertension

Intervention

Hypertensive patients were recruited from physicians’ waiting rooms in two primary and one tertiary health care centers in Beirut.

Patients who agreed to participate in the study were randomly allocated by the research team to either home self-monitoring of blood pressure with educational sessions; or standard of care group, based on a computer-generated series of numbers.

Face-to-face interviews were conducted with all participants at baseline and 6 weeks later at endline.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Feasibility of the intervention, assessed in the self-monitoring of blood pressure group using three indicators at endline (6 weeks):
1.1. Recruitment rates and retention rates (i.e. the percentage of patients from the self-monitoring group who completed the 6-week study)
1.2. The extent to which participants adhere to the BP measurements protocol
1.3. Responses of patients to the questions of how likely they are to continue using the device on a regular basis and to discuss the educational information with their acquaintances
2. Acceptability of the intervention, measured in the endline questionnaire of the self-monitoring group by responses to open-ended questions about patients’ experiences and opinions regarding self-monitoring of BP and educational materials
3. Blood pressure measured at baseline and endline

Secondary outcome measures

1. Understanding of the information provided during educational sessions measured using a questionnaire at baseline and endline
2. Patient engagement:
2.1. Reported changes in lifestyle habits over the course of the 6-week study, including physical activity levels, salt intake, dietary intake, stress management, and smoking habits, assessed during the endline interview
2.2. Medication adherence assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8) at baseline and endline

Overall trial start date

01/04/2016

Overall trial end date

02/04/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Lebanese adults (aged 18+)
2. Prior diagnosis of hypertension

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80 participants

Participant exclusion criteria

1. Spouse is a participant in the study
2. Physical or mental health conditions that would interfere with adequate monitoring of BP

Recruitment start date

01/07/2018

Recruitment end date

30/09/2018

Locations

Countries of recruitment

Lebanon

Trial participating centre

American University of Beirut Medical Center
Bliss Street
Beirut
1107
Lebanon

Trial participating centre

Howard Karagheusian Commemorative Corporation
Burj Hammoud
Beirut
000
Lebanon

Trial participating centre

Amel Association
Haret Hreik
Beirut
000
Lebanon

Sponsor information

Organisation

American University of Beirut

Sponsor details

Bliss Street
Beirut
1107
Lebanon
+961 (0)1350000
hg15@aub.edu.lb

Sponsor type

University/education

Website

http://www.aub.edu.lb

Funders

Funder type

University/education

Funder name

Harvard Medical School Center for Global Health Delivery - Dubai

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Self-monitoring of blood pressure to improve hypertension management in a middle-income country: A proof of concept study – manuscript to be submitted by end of March to BMC Public Health
2. Patient engagement in a middle-income country: Patients’ experiences with self-monitoring of blood pressure – planned publication in a high-impact peer-reviewed journal

The study protocol and statistical analysis plan will not be available.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Hala Ghattas (hg15@aub.edu.lb). Data can be made available after an embargo period of 2 years. All data are de-identified, and a de-identified subset of data can be shared upon submission of a research proposal to the study team.

Intention to publish date

31/03/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

19/02/2020: Trial's existence confirmed by American University of Beirut Institutional Review Board.