Clinical trial NCT03442257: Text Message Intervention for Prevention of Cardiovascular Disease in Primary Care Patients With Hypertension
Official title: PUSH ME (Primary Care USage of Health Promoting Messages): A Text Message-based Intervention for Prevention of Cardiovascular Disease in Primary Care Patients With Hypertension: a Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cardiovascular Risk Factor
Keywords: Hypertension
Text Messaging
Primary Prevention
Cardiovascular Risk Factor
Primary Health Care
Health Promotion
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 59
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to examine the impact of lifestyle advices, administered through regularly sent SMS, on hypertension in a primary health care setting. The secondary objective is to evaluate changes in other cardiovascular risk factors and general health, e.g. tobacco use, obesity, blood lipids, blood glucose, self-rated health and health-related quality of life.

Detailed description: Background- The globalization of unhealthy lifestyles and demographic ageing of the world's population has contributed to the fact that high blood pressure is classified by World Health Organization as the world's leading risk for mortality.

Persistent hypertension is a key risk factor for coronary heart disease (CHD), stroke and other cardiovascular diseases (CVD), such as heart failure. CVD is, despite a decline in recent decades, still the leading cause of death in Sweden (4). The prevalence of hypertension in adults is around 40% according to a recent multinational study (5). In 30-40% of hypertensive individuals, additional metabolic risk factors such as dyslipidemia, insulin resistance and elevated glucose occur simultaneously, which further multiply the risk for heart disease, diabetes and stroke. An unhealthy lifestyle with physical inactivity and excess energy intake is the major driver of these metabolic risk factors. In most cases lifestyle intervention can reverse or reduce the unfavorable metabolic profile.

Primary healthcare in Sweden is managing the first-line healthcare, offering both prevention and treatment for a majority of chronic diseases. In Sweden, the vast majority of patients with hypertension are treated in primary health care. If the hypertension is well controlled, the GP typically meets the patient once a year for medical checkup, blood tests and medical prescription.

Interventions by SMS-texting have been shown to significantly improve compliance to medications, follow-up rate or disease monitoring.

Trial Design - Randomised clinical trial

Intervention - The experimental treatment will consist of an SMS-intervention addressing metabolic risk factors associated with cardiovascular disorders in patients with hypertension.

After baseline measurement participants in the intervention group will receive four semi-personalized messages per week in addition to their usual care according to the National Board of Health and Welfare guidelines for hypertension treatment. The text messages will be developed to support healthy life style changes i.e. regarding general cardiovascular health, tobacco use, physical activity and diet.

Control Treatment - The control group will receive usual care according to the National Board of Health and Welfare guidelines for hypertension treatment.

Recruitment - The participants will be recruited consecutively from three different PHCCs in Skåne. Patients with hypertension will receive information about the study at their annual check-up or other appointment with their GP. If they choose to participate, they will be contacted by phone by a research assistant for additional information, possibility to ask questions about the study, and scheduling a baseline control at their PHCC.

Baseline examination - Included patients that consent to take part in the study will be invited to their PHCC for a baseline visit. The following measurements will be assessed by a research assistant: blood pressure (in sitting position after 5 minutes rest; mean of two measurements in a standardized procedure with validated electronic BP devices), BMI and waist-hip circumference. Furthermore, the patients will complete a short questionnaire for evaluation of medical history, medication, tobacco and alcohol use, physical activity level, self-rated health and health-related quality of life. Blood samples for fasting plasma glucose, HbA1c and cholesterol will be drawn in the morning within a few days after the baseline visit.

Randomization- Randomization to study groups will be performed after completion of baseline assessments and questionnaires. A computer generated random number schedule with block sizes of four will be prepared. To assure allocation concealment, the information about group affiliation will be delivered through sealed envelopes.

The research assistant, the patients' GPs, as well as all researchers except Magnus Sandberg (MS) will be blinded to group allocation. If the patients have questions regarding the SMS function they will be able to contact MS for help.

Follow up- Follow up control will be performed after 6 months with the same assessments as at the baseline visit.

Power and sample size - For the pilot study we have assumed that a total number of 60 patients (20 patients per PHCC) will be sufficient to evaluate the feasibility of the intervention and the logistics of the assessments.

For the future full scale study, each group must contain 143 participants. The sample size is based on an assumed statistical power of 80 %, a two-sided test, a significance level of 5 %, a difference of 5 mm Hg between the groups, a standard deviation of 14 mm Hg and a drop out rate of 15 %.

Analysis plan - Data will be analysed according to the Intention-to-treat principle. Differences in mean change of end points between intervention and control groups will be calculated by ANCOVA, with baseline values as covariates.

Eligibility criteria: Inclusion Criteria:

1. Patients with hypertension (defined by the International classification of disease Manual ICD-10, diagnose code I10.9).
2. 40 to 80 years of age
3. Patient must own a mobile phone compatible with SMS

Exclusion Criteria:

1. History of myocardial infarction, stroke, transient ischemic attack (TIA), claudicatio intermittens, abdominal aortic aneurysm, previous heart surgery i.e. PCI or bypass (reported by recruiting physician or by patient in the questionnaire)
2. Blood pressure at baseline visit ≥180/110 mmHg or systolic blood pressure \<120 mmHg.
3. Serious illness, other than cardiovascular, with short life expectancy (\<1 year)
4. Predicted inability to comply with the study protocol e.g. language difficulties, interpreter needs, serious cognitive impairment.

Primary outcomes:
measure: Change in blood pressure
timeFrame: Six months
Secondary outcomes:
measure: Changes in cholesterol
timeFrame: six months
measure: Changes in high-density lipoprotein [HDL]
timeFrame: six months
measure: Changes in low-density lipoprotein [LDL]
timeFrame: six months
measure: Changes in tobacco use
timeFrame: six months
measure: Changes in BMI
timeFrame: six months
measure: Changes in Blood glucose
timeFrame: six months
measure: Changes in self-rated health
timeFrame: six months
measure: Changes in self rated quality of life
timeFrame: six months
measure: Changes in level of physical activity
timeFrame: six months
measure: Changes in alcohol use
timeFrame: six months
Other outcomes:
Locations:
city: Lomma
country: Sweden
facility: Lomma vårdcentral
state: Skåne
city: Löddeköpinge
country: Sweden
facility: Löddeköpinge vårdcentral
state: Skåne
city: Malmö
country: Sweden
facility: Sorgenfri vårdcentral
state: Skåne
Study officials:
References:
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citation: Chow CK, Redfern J, Hillis GS, Thakkar J, Santo K, Hackett ML, Jan S, Graves N, de Keizer L, Barry T, Bompoint S, Stepien S, Whittaker R, Rodgers A, Thiagalingam A. Effect of Lifestyle-Focused Text Messaging on Risk Factor Modification in Patients With Coronary Heart Disease: A Randomized Clinical Trial. JAMA. 2015 Sep 22-29;314(12):1255-63. doi: 10.1001/jama.2015.10945.
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