Engaging patients in managing hypertension: patient experience with self-monitoring of blood pressure
| ISRCTN | ISRCTN16450193 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16450193 |
| Secondary identifying numbers | FHS.HG.13/SBS-2017-0612 |
- Submission date
- 11/02/2020
- Registration date
- 03/04/2020
- Last edited
- 27/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Bliss Street
Beirut
1107
Lebanon
| Phone | +961 (0)3410366 |
|---|---|
| ca36@aub.edu.lb |
Scientific
Principal Investigator
Center for Research on Population and Health, Faculty of Health Sciences
American University of Beirut
Van Dyck Building
Room 338
Beirut
-
Lebanon
| Phone | +961 (0)1 350000 ext: 4679 |
|---|---|
| hg15@aub.edu.lb |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Engaging patients in managing hypertension: patient experience with self-monitoring of blood pressure |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2016 |
| Completion date | 02/04/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 participants |
| Total final enrolment | 80 |
| Key inclusion criteria | 1. Lebanese adults (aged 18+) 2. Prior diagnosis of hypertension |
| Key exclusion criteria | 1. Spouse is a participant in the study 2. Physical or mental health conditions that would interfere with adequate monitoring of BP |
| Date of first enrolment | 01/07/2018 |
| Date of final enrolment | 30/09/2018 |
Locations
Countries of recruitment
- Lebanon
Study participating centres
Beirut
1107
Lebanon
Beirut
000
Lebanon
Beirut
000
Lebanon
Sponsor information
University/education
Bliss Street
Beirut
1107
Lebanon
| Phone | +961 (0)1350000 |
|---|---|
| hg15@aub.edu.lb | |
| Website | http://www.aub.edu.lb |
"ROR" |
https://ror.org/04pznsd21 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 31/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 27/05/2021 | 27/05/2021 | No | No |
Additional files
- ISRCTN16450193_BasicResults_27May2021.pdf
- uploaded 27/05/2021
Editorial Notes
27/05/2021: The following changes were made to the trial record:
1. The basic results have been uploaded as an additional file.
2. The total final enrolment was added.
19/02/2020: Trial's existence confirmed by American University of Beirut Institutional Review Board.
