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

This study has been completed.
Sponsor:
Collaborator:
Department of Health, Philippines
Information provided by (Responsible Party):
Lia M. Palileo, University of the Philippines
ClinicalTrials.gov Identifier:
NCT01255436
First received: December 6, 2010
Last updated: January 6, 2017
Last verified: January 2017
  Purpose

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.


Condition Intervention
Hypertension Other: SMS text reminders Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Lia M. Palileo, University of the Philippines:

Primary Outcome Measures:
  • Mean Absolute Change in Systolic Blood Pressure After 12 Weeks [ Time Frame: baseline and 12 weeks ]
    Absolute change in systolic blood pressure from baseline to 12 weeks

  • Mean Absolute Change in Diastolic Blood Pressure After 12 Weeks [ Time Frame: baseline and 12 weeks ]
    Absolute change in diastolic blood pressure from baseline to 12 weeks


Secondary Outcome Measures:
  • Medication Adherence Rate [ Time Frame: 12 weeks ]
    The percentage of patients with an improvement of at least one point in adherence score as measured by the Adherence Self-Report Questionnaire at the end of 12 weeks Scale Range: 1 to 6, with 1 being the highest (most adherent) and 6 being the lowest (least adherent)

  • Percentage of Patients With Controlled Blood Pressure at the End of 12 Weeks [ Time Frame: 12 weeks ]
    The percentage of patients with systolic blood pressure less than 140 mmHg and diastolic blood pressure less than 90 mmHg at the end of 12 weeks


Enrollment: 700
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SMS text reminders
Participants in this arm will receive SMS text messages on top of the usual care they receive from their physicians.
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
Participants in this arm will receive the usual care they receive from their physicians.
Other: Usual Care
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.
Other Name: No SMS text reminders

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255436

Locations
Philippines
Philippine General Hospital
Manila, Philippines, 1000
Sponsors and Collaborators
University of the Philippines
Department of Health, Philippines
Investigators
Principal Investigator: Lia M. Palileo, MD University of the Philippines Manila
  More Information

Responsible Party: Lia M. Palileo, Clinical Associate Professor, University of the Philippines
ClinicalTrials.gov Identifier: NCT01255436     History of Changes
Other Study ID Numbers: GCS IM 2010-002 (R-006TE)
Study First Received: December 6, 2010
Results First Received: August 31, 2012
Last Updated: January 6, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 23, 2017