Effectiveness of SMS Text Reminders to Improve Blood Pressure Among Patients With Hypertension

Hypertension Clinical Trial

Official title:

Effectiveness of SMS Text Reminders to Improve Blood Pressure Among Patients With Hypertension at a General Medicine Outpatient Clinic in a Tertiary Center in Manila, Philippines: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255436
• Other study ID #: GCS IM 2010-002 (R-006TE)
• Status: Completed
• Phase: N/A
• First received: December 6, 2010
• Last updated: October 6, 2012
• Start date: January 2011
• Est. completion date: July 2012

Study information

• Verified date: October 2012
• Source: University of the Philippines
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if mobile phone text messages (SMS) will improve blood pressure among hypertensive patients consulting at a General Medicine Outpatient Clinic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Ambulatory adult patients of both sexes with age at least 19 years old being seen at the General Medicine Outpatient Clinic of the Philippine General Hospital

• A diagnosis of hypertension in the medical record

• On at least 1 maintenance medication for hypertension for at least 1 month

• A systolic blood pressure greater than 129 mmHg and less than 160 mmHg or a diastolic blood pressure greater than 79 mmHg or less than 100 mmHg at the time of screening

• Patients with daily access to a mobile phone in the household

• Patients who live with someone who knows how to retrieve and read text messages on their mobile phone, and can relay these messages to them

• Written informed consent

Exclusion Criteria:

• Participation in other studies within one month of trial initiation

• Patients who are unable or refuse to give informed consent

• Patients who have a clinical condition that might interfere with the study (dementia, psychological disorder)

• Patients who share a household with another patient who has already been recruited to participate in this study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• SMS text reminders
Patients in the intervention arm will receive 2 text messages per week delivered via SMS on randomly chosen days and times during the 12-week study period. The aims of the messages are to remind patients to take their blood pressure medications daily, what the target blood pressure is, and the benefits of daily intake of anti-hypertensive medications.
• Usual Care
Routine care of hypertensive patients that is based on recommendations of the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. This consists of physician visits, advice and medication prescription by the healthcare provider. Patients receiving usual care do not receive SMS text reminders.

Locations

Country	Name	City	State
Philippines	Philippine General Hospital	Manila

Sponsors (3)

Lead Sponsor	Collaborator
University of the Philippines	Department of Health, Philippines, Philippine Council for Health Research and Development

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Absolute Change in Systolic Blood Pressure After 12 Weeks	mean difference in systolic blood pressure between baseline and 12 weeks	baseline and 12 weeks	No
Primary	Mean Absolute Change in Diastolic Blood Pressure After 12 Weeks	mean difference in diastolic blood pressure between baseline and 12 weeks	baseline and 12 weeks	No
Secondary	Medication Adherence Rate	The percentage of patients with an improvement of at least one point in adherence score as measured by the Adherence Self-Report Questionnaire Scale Range: 1 to 6, with 1 being the highest (most adherent) and 6 being the lowest (least adherent)	12 weeks	No
Secondary	Patients With Controlled Blood Pressure	The number of patients with systolic blood pressure less than 140 mmHg and diastolic blood pressure less than 90 mmHg	12 weeks	No