An interventional study of SMS group in Hypertension and Cardiovascular Risk Factor, sponsored by Lund University. Completed at 9 sites in Sweden. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-07-05.
Sponsored by Lund University · Not applicable, Interventional, and Treatment
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 400 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Lund University is the lead sponsor of 230 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: SMS group
The control group will receive usual care according to the National Board of Health and Welfare guidelines for hypertension treatment.
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.
Change in blood pressure
Measured by automated devices (mmHg)
Time frame: six months
Changes in cholesterol
Measured by blood test, total cholesterol (mmol/l)
Time frame: six months
Changes in high-density lipoprotein [HDL]
Measured by blood test, high-density lipoprotein \[HDL\] (mmol/l)
Time frame: six months
Changes in low-density lipoprotein [LDL]
Measured by blood test, low-density lipoprotein \[LDL\] (mmol/l)
Time frame: six months
Changes in tobacco use
self-reported. Do you smoke?: 1. Yes, 2. No, 3. Previous smoker. Any changes during study period will be registered.
Time frame: six months
Changes in Blood glucose
HbA1c
Time frame: six months
Changes in self-rated health
five-graded Likert scale from excellent to poor. The question posed is; in general, would you say that you health is excellent, very good, good, fair, or poor?
Time frame: six months
Changes in self rated quality of life
EQ5D-5L (EuroQol 5 dimentions).The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Time frame: six months
Changes in level of physical activity
self-reported physical activity: How much time do you spend during a typical week doing physical exercise, which will make you feel short of breath, such as running, fitness calsses, ball sports? 1. No time, 2. 0-29 min, 3. 30-59 min, 4. 60-120 min, 5.\>120 minHow much time do you spend during a typical week doing everyday exercise, such as walking, cycling, gardening? Adding together all the time (at least 10 minutes at the time) 1. No time, 2. 0-29 min, 3. 30-59 min, 4. 60-119 min, 5. 2-3 h, 6. \>3-5 h, 7. \>5 h
Time frame: six months
Changes in alcohol use
self-reported. Do you drink alcohole? (wine, beer or spirits) See explanation of the term "standard glass of alcohole" 1. No, or \<1 glass/w, 2. 1-4 g/w, 3. 5-8 g/w, 4. 9-12 g/w, 5. 13-19 g/w, 6. \>20g/w
Time frame: six months
Plan to share: Yes — Individual participant data that underlie the results, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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