AzTrials
AzTrials

HypertensionPUSHMENCT04407962

Primary Care Usage of Health Promoting Messages

A study testing SMS group in people with Hypertension and Cardiovascular Risk Factor, run by Lund University at 9 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Hypertension, Cardiovascular Risk Factor
What is being tested?
SMS group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
9 sitesSweden
Study dates
1 Sep 2020to 15 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Sweden9 sites

  • Bokskogens Health Care Center

    Bara

  • Laröds Health Care Center

    Helsingborg

  • Vårdcentralen Delfinen

    Höganäs

  • Vårdcentralen Nötkärnan

    Kållered

  • Nöbbelövs Health Care Center

    Lund

  • Rävlanda vårdcentral

    Rävlanda

  • Närhälsan Tidaholm

    Tidaholm

  • Skärvet Health Care Center

    Vaxjo, 35236

  • Hovshaga Health Care Center

    Vaxjo, 35261

Other trials in Sweden

About this study

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

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.

Read the 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.

Being tested
SMS group
Keywords
Hypertension, Text messaging, Primary Health Care, Health Promotion, Cardiovascular Risk Factor, Quality of Life
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SMS groupBehavioural

    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.

Study groups in NCT04407962
Study groupRoleWhat they receive
SMS groupExperimentalParticipants 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.
Receives: Behavioral: SMS group
Control groupNo interventionThe control group will receive usual care according to the National Board of Health and Welfare guidelines for hypertension treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in blood pressure

    Measured by automated devices (mmHg)

    Measured: six months

Secondary outcomes (9)

  1. Changes in cholesterol

    Measured by blood test, total cholesterol (mmol/l)

    Measured: six months

  2. Changes in high-density lipoprotein [HDL]

    Measured by blood test, high-density lipoprotein [HDL] (mmol/l)

    Measured: six months

  3. Changes in low-density lipoprotein [LDL]

    Measured by blood test, low-density lipoprotein [LDL] (mmol/l)

    Measured: six months

  4. Changes in tobacco use

    self-reported. Do you smoke?: 1. Yes, 2. No, 3. Previous smoker. Any changes during study period will be registered.

    Measured: six months

  5. Changes in Blood glucose

    HbA1c

    Measured: six months

  6. Changes in self-rated health

    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?

    Measured: six months

  7. Changes in self rated quality of life

    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'.

    Measured: six months

  8. Changes in level of physical activity

    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

    Measured: six months

  9. Changes in alcohol use

    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

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2020
  2. Study start1 Sep 2020
  3. Primary completion15 Jun 2023
  4. Study completion15 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04407962
Sponsor's protocol ID
2019-06361
Other IDs
2019
Acronym
PUSHME
Status last verified
Jul 2023
First submitted
25 May 2020
Last updated
5 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results, after deidentification (text, tables, figures, and appendices).

Publications

  • 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.

    PubMed 27863813

  • 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.

    PubMed 28919119

  • 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.

    PubMed 15145106

  • 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.

    PubMed 19805654

  • 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.

    PubMed 26654259

  • 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.

    PubMed 22643153

  • 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.

    PubMed 23117563

  • 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.

    PubMed 27095386

  • 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.

    PubMed 26903176

  • 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.

    PubMed 26456490

  • 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.

    PubMed 26393848

  • 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.

    PubMed 25952653

  • 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.

    PubMed 10163601

  • 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.

    PubMed 15367073

  • 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.

    PubMed 17448248

Questions about this trial

What is this clinical trial studying?

A study testing SMS group in people with Hypertension and Cardiovascular Risk Factor, run by Lund University at 9 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in blood pressure (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04407962, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in