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

This study has been completed.
Sponsor:
Collaborators:
Department of Health, Philippines
Philippine Council for Health Research and Development
Information provided by (Responsible Party):
Lia M. Palileo, University of the Philippines
ClinicalTrials.gov Identifier:
NCT01255436
First received: December 6, 2010
Last updated: October 6, 2012
Last verified: October 2012
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by University of the Philippines:

Primary Outcome Measures:
  • Mean Absolute Change in Systolic Blood Pressure After 12 Weeks [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    mean difference in systolic blood pressure between baseline and 12 weeks

  • Mean Absolute Change in Diastolic Blood Pressure After 12 Weeks [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    mean difference in diastolic blood pressure between baseline and 12 weeks


Secondary Outcome Measures:
  • Medication Adherence Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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)

  • Patients With Controlled Blood Pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The number of patients with systolic blood pressure less than 140 mmHg and diastolic blood pressure less than 90 mmHg


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 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.
Placebo Comparator: No SMS text reminders Other: 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Philippine Council for Health Research and Development
Investigators
Principal Investigator: Lia M. Palileo, MD University of the Philippines Manila
  More Information

No publications provided

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: October 6, 2012
Health Authority: Philippines: Ethics Committee

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014