Effectiveness of SMS Text Reminders to Improve Blood Pressure Among Patients With Hypertension
This study has been completed.
Sponsor:
University of the Philippines
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
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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
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 Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013