Primary Care Usage of Health Promoting Messages (PUSHME)

July 3, 2023 updated by: Lund University

PUSHME (Primary Care USage of Health Promoting Messages): A Text Message-based Intervention in Primary Care Patients With Hypertension: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Bara, Sweden
        • Bokskogens Health Care Center
      • Helsingborg, Sweden
        • Laröds Health Care Center
      • Höganäs, Sweden
        • Vårdcentralen Delfinen
      • Kållered, Sweden
        • Vårdcentralen Nötkärnan
      • Lund, Sweden
        • Nöbbelövs Health Care Center
      • Rävlanda, Sweden
        • Rävlanda vårdcentral
      • Tidaholm, Sweden
        • Närhälsan Tidaholm
      • Växjö, Sweden, 35236
        • Skärvet Health Care Center
      • Växjö, Sweden, 35261
        • Hovshaga Health Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SMS group
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 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.
No Intervention: Control group
The control group will receive usual care according to the National Board of Health and Welfare guidelines for hypertension treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood pressure
Time Frame: six months
Measured by automated devices (mmHg)
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in cholesterol
Time Frame: six months
Measured by blood test, total cholesterol (mmol/l)
six months
Changes in high-density lipoprotein [HDL]
Time Frame: six months
Measured by blood test, high-density lipoprotein [HDL] (mmol/l)
six months
Changes in low-density lipoprotein [LDL]
Time Frame: six months
Measured by blood test, low-density lipoprotein [LDL] (mmol/l)
six months
Changes in Blood glucose
Time Frame: six months
HbA1c
six months
Changes in self-rated health
Time Frame: six months
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?
six months
Changes in self rated quality of life
Time Frame: six months
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'.
six months
Changes in tobacco use
Time Frame: six months
self-reported. Do you smoke?: 1. Yes, 2. No, 3. Previous smoker. Any changes during study period will be registered.
six months
Changes in level of physical activity
Time Frame: six months
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
six months
Changes in alcohol use
Time Frame: six months
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
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

May 25, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-06361

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Investigators whose proposed use of the data will be approved by a review committee for this purpose.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on SMS group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe