<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04407962</url>
  </required_header>
  <id_info>
    <org_study_id>2019-06361</org_study_id>
    <nct_id>NCT04407962</nct_id>
  </id_info>
  <brief_title>Primary Care Usage of Health Promoting Messages</brief_title>
  <acronym>PUSHME</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lund University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project aims to investigate the use of e-health to assist health personnel in primary&#xD;
      health care to carry out preventive measures of cardiovascular disease.The primary objective&#xD;
      of the study is to examine the impact of lifestyle advices, administered through regularly&#xD;
      sent SMS, on hypertension in a primary health care setting. The secondary objective is to&#xD;
      evaluate changes in other cardiovascular risk factors and general health, e.g. tobacco use,&#xD;
      obesity, blood lipids, HbA1c, self-rated health and health-related quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomised controlled multi-centre study.The study will involve 400 patients from 9&#xD;
      primary health care centres located in four different regions in Sweden (Region Skåne, Region&#xD;
      Kronoberg, Region Stockholm, Västra Götalandsregionen).&#xD;
&#xD;
      Patients in the intervention group will receive SMS messages aiming to remind, encourage and&#xD;
      motivate patients to pursue healthy lifestyle changes. After baseline measurement,&#xD;
      participants in the intervention group will receive four semi-personalized SMS messages per&#xD;
      week for six months, in addition to their usual anti-hypertensive treatment. Each week, the&#xD;
      participants will receive SMS from each of the following groups: A. Physical activity, B.&#xD;
      Tobacco use, C. Dietary habits, and D. Cardiovascular health in general, except for&#xD;
      non-smokers who, instead of the tobacco use-SMS, will get one extra randomly selected SMS.&#xD;
&#xD;
      Included patients that consent to take part in the study will be invited to their primary&#xD;
      health care centre for a baseline visit. The following measurements will be assessed by a&#xD;
      research assistant: blood pressure (in sitting position after 5 minutes rest; mean of two&#xD;
      measurements in a standardized procedure with validated electronic BP devices), BMI and&#xD;
      waist-hip circumference. Furthermore, the patients will complete a short questionnaire for&#xD;
      evaluation of medical history, medication, tobacco and alcohol use, physical activity level,&#xD;
      self-rated health and health-related quality of life. Blood samples for HbA1c and cholesterol&#xD;
      will be drawn. Randomization will be performed after completion of baseline assessments and&#xD;
      questionnaires. A follow up control will be performed after 6 months with the same&#xD;
      assessments as at the baseline visit.&#xD;
&#xD;
      The primary endpoint is change inblood pressure (mmHg). Secondary endpoints are changes in&#xD;
      Cholesterol (total cholesterol, high-density lipoprotein [HDL], low-density lipoprotein&#xD;
      [LDL]) (mmol/l), Tobacco and alcohol use, BMI (kg/m2), waist circumference, HbA1c (mmol/mol),&#xD;
      Self-rated health (five-graded Likert scale), Health related quality of life, as measured by&#xD;
      EQ5D-5L, Self-reported physical activity.&#xD;
&#xD;
      The power analysis indicates a sample size of 189 patients in each arm. The calculation is&#xD;
      based on an assumed statistical power of 80%, a two-sided test, using a significant level of&#xD;
      5% with a difference of 4 mm Hg between the groups, a standard deviation of 13 mm Hg and a&#xD;
      drop out rate of 15%. Data will be analyzed according to the intention-to-treat principle.&#xD;
      Differences in mean change of endpoints between intervention and control groups will be&#xD;
      calculated by ANCOVA, with baseline values as covariates. Correlation between behavioral&#xD;
      change (smoke cessation,increased level of physical activity) and behavioral predictors will&#xD;
      be analyzed with logistic regression analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">June 15, 2023</completion_date>
  <primary_completion_date type="Actual">June 15, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>six months</time_frame>
    <description>Measured by automated devices (mmHg)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in cholesterol</measure>
    <time_frame>six months</time_frame>
    <description>Measured by blood test, total cholesterol (mmol/l)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in high-density lipoprotein [HDL]</measure>
    <time_frame>six months</time_frame>
    <description>Measured by blood test, high-density lipoprotein [HDL] (mmol/l)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in low-density lipoprotein [LDL]</measure>
    <time_frame>six months</time_frame>
    <description>Measured by blood test, low-density lipoprotein [LDL] (mmol/l)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in tobacco use</measure>
    <time_frame>six months</time_frame>
    <description>self-reported. Do you smoke?: 1. Yes, 2. No, 3. Previous smoker. Any changes during study period will be registered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Blood glucose</measure>
    <time_frame>six months</time_frame>
    <description>HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in self-rated health</measure>
    <time_frame>six months</time_frame>
    <description>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?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in self rated quality of life</measure>
    <time_frame>six months</time_frame>
    <description>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'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in level of physical activity</measure>
    <time_frame>six months</time_frame>
    <description>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.&gt;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. &gt;3-5 h, 7. &gt;5 h</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in alcohol use</measure>
    <time_frame>six months</time_frame>
    <description>self-reported. Do you drink alcohole? (wine, beer or spirits) See explanation of the term &quot;standard glass of alcohole&quot; 1. No, or &lt;1 glass/w, 2. 1-4 g/w, 3. 5-8 g/w, 4. 9-12 g/w, 5. 13-19 g/w, 6. &gt;20g/w</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Hypertension</condition>
  <condition>Cardiovascular Risk Factor</condition>
  <arm_group>
    <arm_group_label>SMS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive usual care according to the National Board of Health and Welfare guidelines for hypertension treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SMS group</intervention_name>
    <description>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.</description>
    <arm_group_label>SMS group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with hypertension (defined by the International classification of disease&#xD;
             Manual ICD-10, diagnose code I10.9)&#xD;
&#xD;
          2. 40-85 years&#xD;
&#xD;
          3. Patient must own a smart mobile phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Blood pressure at baseline visit ≥180/110 mmHg or systolic blood pressure&lt;120 mmHg&#xD;
&#xD;
          2. Serious illness with short life expectancy (&lt;1year)&#xD;
&#xD;
          3. Predicted inability to comply with the study protocol e.g. language difficulties,&#xD;
             interpreter needs, serious cognitive impairment&#xD;
&#xD;
          4. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bokskogens Health Care Center</name>
      <address>
        <city>Bara</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laröds Health Care Center</name>
      <address>
        <city>Helsingborg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vårdcentralen Delfinen</name>
      <address>
        <city>Höganäs</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vårdcentralen Nötkärnan</name>
      <address>
        <city>Kållered</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nöbbelövs Health Care Center</name>
      <address>
        <city>Lund</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rävlanda vårdcentral</name>
      <address>
        <city>Rävlanda</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Närhälsan Tidaholm</name>
      <address>
        <city>Tidaholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skärvet Health Care Center</name>
      <address>
        <city>Växjö</city>
        <zip>35236</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hovshaga Health Care Center</name>
      <address>
        <city>Växjö</city>
        <zip>35261</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in blood pressure from 1975 to 2015: a pooled analysis of 1479 population-based measurement studies with 19.1 million participants. Lancet. 2017 Jan 7;389(10064):37-55. doi: 10.1016/S0140-6736(16)31919-5. Epub 2016 Nov 16. Erratum In: Lancet. 2020 Sep 26;396(10255):886.</citation>
    <PMID>27863813</PMID>
  </reference>
  <reference>
    <citation>GBD 2016 Risk Factors Collaborators. Global, regional, and national comparative risk assessment of 84 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1345-1422. doi: 10.1016/S0140-6736(17)32366-8. Erratum In: Lancet. 2017 Oct 14;390(10104):1736. Lancet. 2017 Oct 28;390(10106):e38.</citation>
    <PMID>28919119</PMID>
  </reference>
  <reference>
    <citation>Schillaci G, Pirro M, Vaudo G, Gemelli F, Marchesi S, Porcellati C, Mannarino E. Prognostic value of the metabolic syndrome in essential hypertension. J Am Coll Cardiol. 2004 May 19;43(10):1817-22. doi: 10.1016/j.jacc.2003.12.049.</citation>
    <PMID>15145106</PMID>
  </reference>
  <reference>
    <citation>Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.</citation>
    <PMID>19805654</PMID>
  </reference>
  <reference>
    <citation>Grundy SM. Metabolic syndrome update. Trends Cardiovasc Med. 2016 May;26(4):364-73. doi: 10.1016/j.tcm.2015.10.004. Epub 2015 Oct 31.</citation>
    <PMID>26654259</PMID>
  </reference>
  <reference>
    <citation>Lindblad U, Ek J, Eckner J, Larsson CA, Shan G, Rastam L. Prevalence, awareness, treatment, and control of hypertension: rule of thirds in the Skaraborg project. Scand J Prim Health Care. 2012 Jun;30(2):88-94. doi: 10.3109/02813432.2012.684207.</citation>
    <PMID>22643153</PMID>
  </reference>
  <reference>
    <citation>Cottrell E, Chambers R, O'Connell P. Using simple telehealth in primary care to reduce blood pressure: a service evaluation. BMJ Open. 2012 Oct 31;2(6):e001391. doi: 10.1136/bmjopen-2012-001391. Print 2012.</citation>
    <PMID>23117563</PMID>
  </reference>
  <reference>
    <citation>Arambepola C, Ricci-Cabello I, Manikavasagam P, Roberts N, French DP, Farmer A. The Impact of Automated Brief Messages Promoting Lifestyle Changes Delivered Via Mobile Devices to People with Type 2 Diabetes: A Systematic Literature Review and Meta-Analysis of Controlled Trials. J Med Internet Res. 2016 Apr 19;18(4):e86. doi: 10.2196/jmir.5425.</citation>
    <PMID>27095386</PMID>
  </reference>
  <reference>
    <citation>Mussener U, Bendtsen M, Karlsson N, White IR, McCambridge J, Bendtsen P. Effectiveness of Short Message Service Text-Based Smoking Cessation Intervention Among University Students: A Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):321-8. doi: 10.1001/jamainternmed.2015.8260.</citation>
    <PMID>26903176</PMID>
  </reference>
  <reference>
    <citation>Bengtsson U, Kjellgren K, Hallberg I, Lindwall M, Taft C. Improved Blood Pressure Control Using an Interactive Mobile Phone Support System. J Clin Hypertens (Greenwich). 2016 Feb;18(2):101-8. doi: 10.1111/jch.12682. Epub 2015 Oct 12.</citation>
    <PMID>26456490</PMID>
  </reference>
  <reference>
    <citation>Chow CK, Redfern J, Hillis GS, Thakkar J, Santo K, Hackett ML, Jan S, Graves N, de Keizer L, Barry T, Bompoint S, Stepien S, Whittaker R, Rodgers A, Thiagalingam A. Effect of Lifestyle-Focused Text Messaging on Risk Factor Modification in Patients With Coronary Heart Disease: A Randomized Clinical Trial. JAMA. 2015 Sep 22-29;314(12):1255-63. doi: 10.1001/jama.2015.10945. Erratum In: JAMA. 2016 Mar 8;315(10):1057.</citation>
    <PMID>26393848</PMID>
  </reference>
  <reference>
    <citation>Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Maciosek MV, Nyboer RA, O'Connor PJ, Pawloski PA, Sperl-Hillen JM, Trower NK, Tucker AD, Green BB. A Successful Multifaceted Trial to Improve Hypertension Control in Primary Care: Why Did it Work? J Gen Intern Med. 2015 Nov;30(11):1665-72. doi: 10.1007/s11606-015-3355-x.</citation>
    <PMID>25952653</PMID>
  </reference>
  <reference>
    <citation>Godin G, Kok G. The theory of planned behavior: a review of its applications to health-related behaviors. Am J Health Promot. 1996 Nov-Dec;11(2):87-98. doi: 10.4278/0890-1171-11.2.87.</citation>
    <PMID>10163601</PMID>
  </reference>
  <reference>
    <citation>Johnston DW, Johnston M, Pollard B, Kinmonth AL, Mant D. Motivation is not enough: prediction of risk behavior following diagnosis of coronary heart disease from the theory of planned behavior. Health Psychol. 2004 Sep;23(5):533-8. doi: 10.1037/0278-6133.23.5.533.</citation>
    <PMID>15367073</PMID>
  </reference>
  <reference>
    <citation>Palmeira AL, Teixeira PJ, Branco TL, Martins SS, Minderico CS, Barata JT, Serpa SO, Sardinha LB. Predicting short-term weight loss using four leading health behavior change theories. Int J Behav Nutr Phys Act. 2007 Apr 20;4:14. doi: 10.1186/1479-5868-4-14.</citation>
    <PMID>17448248</PMID>
  </reference>
  <reference>
    <citation>Owen N, Sugiyama T, Eakin EE, Gardiner PA, Tremblay MS, Sallis JF. Adults' sedentary behavior determinants and interventions. Am J Prev Med. 2011 Aug;41(2):189-96. doi: 10.1016/j.amepre.2011.05.013.</citation>
    <PMID>21767727</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>July 3, 2023</last_update_submitted>
  <last_update_submitted_qc>July 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Text messaging</keyword>
  <keyword>Primary Health Care</keyword>
  <keyword>Health Promotion</keyword>
  <keyword>Cardiovascular Risk Factor</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results, after deidentification (text, tables, figures, and appendices).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication.</ipd_time_frame>
    <ipd_access_criteria>Investigators whose proposed use of the data will be approved by a review committee for this purpose.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04407962
org study id: 2019-06361
nct id: NCT04407962
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled Trial
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Change in blood pressure
time frame: six months
description: Measured by automated devices (mmHg)
measure: Changes in cholesterol
time frame: six months
description: Measured by blood test, total cholesterol (mmol/l)
measure: Changes in high-density lipoprotein [HDL]
time frame: six months
description: Measured by blood test, high-density lipoprotein [HDL] (mmol/l)
measure: Changes in low-density lipoprotein [LDL]
time frame: six months
description: Measured by blood test, low-density lipoprotein [LDL] (mmol/l)
measure: Changes in tobacco use
time frame: six months
description: self-reported. Do you smoke?: 1. Yes, 2. No, 3. Previous smoker. Any changes during study period will be registered.
measure: Changes in Blood glucose
time frame: six months
description: HbA1c
measure: Changes in self-rated health
time frame: six months
description: 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?
measure: Changes in self rated quality of life
time frame: six months
description: 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'.
measure: Changes in level of physical activity
time frame: six months
description: 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
measure: Changes in alcohol use
time frame: six months
description: 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
arm group label: SMS group
arm group type: Experimental
description: 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.
arm group label: Control group
arm group type: No Intervention
description: The control group will receive usual care according to the National Board of Health and Welfare guidelines for hypertension treatment.
intervention type: Behavioral
intervention name: SMS group
description: 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.
arm group label: SMS group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
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country: Sweden
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PMID: 27863813
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PMID: 28919119
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PMID: 15145106
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PMID: 19805654
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PMID: 26654259
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PMID: 23117563
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PMID: 27095386
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responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: Yes
ipd description: Individual participant data that underlie the results, after deidentification (text, tables, figures, and appendices).
ipd info type: Study Protocol
ipd time frame: Beginning 9 months and ending 36 months following article publication.
ipd access criteria: Investigators whose proposed use of the data will be approved by a review committee for this purpose.