- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04407962
Primary Care Usage of Health Promoting Messages (PUSHME)
PUSHME (Primary Care USage of Health Promoting Messages): A Text Message-based Intervention in Primary Care Patients With Hypertension: a Randomized Controlled Trial
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Moa Wolff, PhD
- Phone Number: +46702844240
- Email: moa.wolff@med.lu.se
Study Contact Backup
- Name: Beata Borgstöm Bolmsjö, PhD
- Phone Number: +46739244149
- Email: beata.borgstrom_bolmsjo@med.lu.se
Study Locations
-
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with hypertension (defined by the International classification of disease Manual ICD-10, diagnose code I10.9)
- 40-85 years
- Patient must own a smart mobile phone
Exclusion Criteria:
- Blood pressure at baseline visit ≥180/110 mmHg or systolic blood pressure<120 mmHg
- Serious illness with short life expectancy (<1year)
- Predicted inability to comply with the study protocol e.g. language difficulties, interpreter needs, serious cognitive impairment
- Pregnancy
Study Plan
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.
|
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
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Addpharma Inc.Completed
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
Clinical Trials on SMS group
-
The University of Hong KongCompletedSmoking CessationHong Kong
-
The University of Hong KongCompletedComparative Effectiveness Research | Community-Based Participatory ResearchChina
-
University of BaselCompletedSedentary LifestyleSwitzerland
-
Seva FoundationQueen's University, Belfast; Bharatpur Eye Hospital; Indian Institute of Public... and other collaboratorsCompletedConjunctivitis | Strabismus | Amblyopia | Corneal Ulcer | Eye Injuries | CNLDO - Congenital Nasolacrimal Duct ObstructionNepal
-
The University of Hong KongRecruiting
-
NYU Langone HealthCompleted
-
Clalit Health ServicesUnknown
-
Boston UniversityCompleted
-
Rush University Medical CenterCompletedOsteoarthritis, Knee | Osteoarthritis, Hip
-
University of California, San FranciscoCompletedIntegrative Palliative Care/Psycho-Oncology Telehealth Intervention in Patients With Advanced CancerAdvanced Malignant Solid Neoplasm | Locally Advanced Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States