Primary Care Usage of Health Promoting Messages
Condition: Hypertension; Cardiovascular Risk Factor
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This project aims to investigate the use of e-health to assist health personnel in primary
      health care to carry out preventive measures of cardiovascular disease.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, HbA1c, self-rated health and health-related quality of life.
    

Detailed description: 
      This is a randomised controlled multi-centre study.The study will involve 400 patients from 9
      primary health care centres located in four different regions in Sweden (Region Skåne, Region
      Kronoberg, Region Stockholm, Västra Götalandsregionen).

      Patients in the intervention group will receive SMS messages aiming to remind, encourage and
      motivate patients to pursue healthy lifestyle changes. After baseline measurement,
      participants in the intervention group will receive four semi-personalized SMS messages per
      week for six months, in addition to their usual anti-hypertensive treatment. Each week, the
      participants will receive SMS from each of the following groups: A. Physical activity, B.
      Tobacco use, C. Dietary habits, and D. Cardiovascular health in general, except for
      non-smokers who, instead of the tobacco use-SMS, will get one extra randomly selected SMS.

      Included patients that consent to take part in the study will be invited to their primary
      health care centre 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 HbA1c and cholesterol
      will be drawn. Randomization will be performed after completion of baseline assessments and
      questionnaires. A follow up control will be performed after 6 months with the same
      assessments as at the baseline visit.

      The primary endpoint is change inblood pressure (mmHg). Secondary endpoints are changes in
      Cholesterol (total cholesterol, high-density lipoprotein [HDL], low-density lipoprotein
      [LDL]) (mmol/l), Tobacco and alcohol use, BMI (kg/m2), waist circumference, HbA1c (mmol/mol),
      Self-rated health (five-graded Likert scale), Health related quality of life, as measured by
      EQ5D-5L, Self-reported physical activity.

      The power analysis indicates a sample size of 189 patients in each arm. The calculation is
      based on an assumed statistical power of 80%, a two-sided test, using a significant level of
      5% with a difference of 4 mm Hg between the groups, a standard deviation of 13 mm Hg and a
      drop out rate of 15%. Data will be analyzed according to the intention-to-treat principle.
      Differences in mean change of endpoints between intervention and control groups will be
      calculated by ANCOVA, with baseline values as covariates. Correlation between behavioral
      change (smoke cessation,increased level of physical activity) and behavioral predictors will
      be analyzed with logistic regression analysis.
    

Intervention name(s): SMS group
Intervention type(s): Behavioral
Intervention description(s): The experimental treatment will consist of health promoting text messages addressing metabolic risk factors associated with cardiovascular disorders in patients with hypertension. The text messages will be developed to support healthy life style changes i.e. regarding general cardiovascular health, tobacco use, physical activity and diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; Text messaging; Primary Health Care; Health Promotion; Cardiovascular Risk Factor; Quality of Life