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

NCT01255436 | Completed Results DMC

• 1 other identifier: GCS IM 2010-002 (R-006TE)
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To test the primary hypothesis that SMS text messages delivered to patients via mobile phone can improve blood pressure within 12 weeks compared to usual care Design: Parallel group, randomized, controlled trial; the patient is the unit of randomization Setting: General Medicine Outpatient Continuity Clinic of the Philippine General Hospital and Private Outpatient Clinics near the Philippine General Hospital Patients: Ambulatory men and women aged 19 years and older (N=700) with a diagnosis of essential hypertension, on maintenance blood pressure-lowering medications, who have daily access to a mobile phone in the household and know or live with someone who knows how to retrieve, read and reply to text messages using a mobile phone Intervention: SMS text messages delivered twice a week for 12 weeks, which aim to 1) provide information regarding hypertension; 2) remind patients to take their medications. Main Outcome Measure: The primary outcomes are the mean change in systolic and diastolic blood pressures at the end of 12 weeks. The secondary outcomes are improvement in blood pressure control rate and medication adherence.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Mean Absolute Change in Systolic Blood Pressure After 12 Weeks

  Absolute change in systolic blood pressure from baseline to 12 weeks

  baseline and 12 weeks

• Mean Absolute Change in Diastolic Blood Pressure After 12 Weeks

  Absolute change in diastolic blood pressure from baseline to 12 weeks

  baseline and 12 weeks

Secondary Outcomes (2)

• Medication Adherence Rate

  12 weeks

• Percentage of Patients With Controlled Blood Pressure at the End of 12 Weeks

  12 weeks

Study Arms (2)

SMS text reminders

EXPERIMENTAL

Participants in this arm will receive SMS text messages on top of the usual care they receive from their physicians.

Other: SMS text reminders

Usual Care

OTHER

Participants in this arm will receive the usual care they receive from their physicians.

Other: Usual Care

Interventions

SMS text reminders OTHER

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.

SMS text reminders

Usual Care OTHER

Patients in the usual care arm will receive the care usually provided by their physicians. This consists of consultations, medical advice, and prescriptions for maintenance medications. They will not be sent any SMS text reminders from the study.

Also known as: No SMS text reminders

Usual Care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Philippines: lead
• Department of Health, Philippines: collaborator

Study Sites (1)

Philippine General Hospital

Manila, 1000, Philippines

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Strong conclusions cannot be made because of the high attrition rate at the end of the study.

Results Point of Contact

• Title: Dr. Lia M. Palileo
• Organization: University of the Philippines Manila

liapalileo@gmail.com

6325679740

Study Officials

• Lia M. Palileo, MD

  University of the Philippines Manila

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 7, 2010
• Study Start: January 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 23, 2017
• Results First Posted: October 2, 2012

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)