Text Message Intervention for Prevention of Cardiovascular Disease in Primary Care Patients With Hypertension (PUSH-ME)
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|ClinicalTrials.gov Identifier: NCT03442257|
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : June 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Cardiovascular Risk Factor||Behavioral: SMS||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The research assistant, the patients' GPs, as well as all researchers except one (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.|
|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|
|Actual Study Start Date :||March 19, 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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.
The experimental treatment will consist of health promoting text messages addressing metabolic risk factors associated with cardiovascular disorders in patients with hypertension. Participants will receive four semi-personalized messages per week in addition to their usual care. 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
The control group will receive usual care according to the National Board of Health and Welfare guidelines for hypertension treatment.
- Change in blood pressure [ Time Frame: Six months ]Measured by automated devices (mmHg)
- Changes in cholesterol [ Time Frame: six months ]Measured by blood test, total cholesterol (mmol/l)
- Changes in high-density lipoprotein [HDL] [ Time Frame: six months ]Measured by blood test, high-density lipoprotein [HDL] (mmol/l)
- Changes in low-density lipoprotein [LDL] [ Time Frame: six months ]Measured by blood test, low-density lipoprotein [LDL] (mmol/l)
- Changes in tobacco use [ Time Frame: six months ]Self-reported
- Changes in BMI [ Time Frame: six months ]Measured by research assistant at baseline and follow up (weight and hight will be combined to report BMI in kg/m2)
- Changes in Blood glucose [ Time Frame: six months ]HbA1c
- 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?
- 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'.
- Changes in level of physical activity [ Time Frame: six months ]self-reported physical activity
- Changes in alcohol use [ Time Frame: six months ]self-reported
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442257
|Contact: Moa Wolff, PhDemail@example.com|
|Contact: Beata Borgström Bolmsjö, PhDfirstname.lastname@example.org|
|Lomma, Skåne, Sweden, 23434|
|Contact: Susanna Calling email@example.com|
|Löddeköpinge, Skåne, Sweden, 24630|
|Contact: Moa Wolff firstname.lastname@example.org|
|Malmö, Skåne, Sweden, 214 33|
|Contact: Beata B Bolmsjö beata.borgström_bolmsjo@med.lu.se|