Clinical trial NCT04407962: Primary Care Usage of Health Promoting Messages
Official title: PUSHME (Primary Care USage of Health Promoting Messages): A Text Message-based Intervention in Primary Care Patients With Hypertension: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cardiovascular Risk Factor
Keywords: Hypertension
Text messaging
Primary Health Care
Health Promotion
Cardiovascular Risk Factor
Quality of Life
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
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: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with hypertension (defined by the International classification of disease Manual ICD-10, diagnose code I10.9)
2. 40-85 years
3. Patient must own a smart mobile phone

Exclusion Criteria:

1. Blood pressure at baseline visit ≥180/110 mmHg or systolic blood pressure\<120 mmHg
2. Serious illness with short life expectancy (\<1year)
3. Predicted inability to comply with the study protocol e.g. language difficulties, interpreter needs, serious cognitive impairment
4. Pregnancy

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 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: Bara
country: Sweden
facility: Bokskogens Health Care Center
city: Helsingborg
country: Sweden
facility: Laröds Health Care Center
city: Höganäs
country: Sweden
facility: Vårdcentralen Delfinen
city: Kållered
country: Sweden
facility: Vårdcentralen Nötkärnan
city: Lund
country: Sweden
facility: Nöbbelövs Health Care Center
city: Rävlanda
country: Sweden
facility: Rävlanda vårdcentral
city: Tidaholm
country: Sweden
facility: Närhälsan Tidaholm
city: Växjö
country: Sweden
facility: Skärvet Health Care Center
city: Växjö
country: Sweden
facility: Hovshaga Health Care Center
Study officials:
References:
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