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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
Sponsor:
Information provided by (Responsible Party):
Lund University

Brief Summary:
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, blood glucose, self-rated health and health-related quality of life.

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
Allocation: Randomized
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.
Primary Purpose: Treatment
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

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
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.



Primary Outcome Measures :
  1. Change in blood pressure [ Time Frame: Six months ]
    Measured by automated devices (mmHg)


Secondary Outcome Measures :
  1. Changes in cholesterol [ Time Frame: six months ]
    Measured by blood test, total cholesterol (mmol/l)

  2. Changes in high-density lipoprotein [HDL] [ Time Frame: six months ]
    Measured by blood test, high-density lipoprotein [HDL] (mmol/l)

  3. Changes in low-density lipoprotein [LDL] [ Time Frame: six months ]
    Measured by blood test, low-density lipoprotein [LDL] (mmol/l)

  4. Changes in tobacco use [ Time Frame: six months ]
    Self-reported

  5. 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)

  6. Changes in Blood glucose [ Time Frame: six months ]
    HbA1c

  7. 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?

  8. 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'.

  9. Changes in level of physical activity [ Time Frame: six months ]
    self-reported physical activity

  10. Changes in alcohol use [ Time Frame: six months ]
    self-reported



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with hypertension (defined by the International classification of disease Manual ICD-10, diagnose code I10.9).
  2. 40 to 80 years of age
  3. Patient must own a mobile phone compatible with SMS

Exclusion Criteria:

  1. History of myocardial infarction, stroke, transient ischemic attack (TIA), claudicatio intermittens, abdominal aortic aneurysm, previous heart surgery i.e. PCI or bypass (reported by recruiting physician or by patient in the questionnaire)
  2. Blood pressure at baseline visit ≥180/110 mmHg or systolic blood pressure <120 mmHg.
  3. Serious illness, other than cardiovascular, with short life expectancy (<1 year)
  4. Predicted inability to comply with the study protocol e.g. language difficulties, interpreter needs, serious cognitive impairment.

Information from the National Library of Medicine

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


Contacts
Contact: Moa Wolff, PhD 0046702844240 moa.wolff@med.lu.se
Contact: Beata Borgström Bolmsjö, PhD 004673944149 beata.borgstrom_bolmsjo@med.lu.se

Locations
Sweden
Lomma vårdcentral Recruiting
Lomma, Skåne, Sweden, 23434
Contact: Susanna Calling       susanna.calling@med.lu.se   
Löddeköpinge vårdcentral Recruiting
Löddeköpinge, Skåne, Sweden, 24630
Contact: Moa Wolff       moa.wolff@med.lu.se   
Sorgenfri vårdcentral Recruiting
Malmö, Skåne, Sweden, 214 33
Contact: Beata B Bolmsjö       beata.borgström_bolmsjo@med.lu.se   
Sponsors and Collaborators
Lund University

Additional Information:
Publications:

Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03442257     History of Changes
Other Study ID Numbers: 2017/674
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lund University:
Hypertension
Text Messaging
Primary Prevention
Cardiovascular Risk Factor
Primary Health Care
Health Promotion

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases