Primary Care Usage of Health Promoting Messages

NCT04407962 | Completed

• 1 other identifier: 2019-06361
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 9

Brief 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 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.

Conditions

Hypertension; Cardiovascular Risk Factor

Keywords

Hypertension; Text messaging; Primary Health Care; Health Promotion; Cardiovascular Risk Factor; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in blood pressure

  Measured by automated devices (mmHg)

  six months

Secondary Outcomes (9)

• Changes in cholesterol

  six months

• Changes in high-density lipoprotein [HDL]

  six months

• Changes in low-density lipoprotein [LDL]

  six months

• Changes in tobacco use

  six months

• Changes in Blood glucose

  six months

Study Arms (2)

SMS group

EXPERIMENTAL

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 group

Control group

NO INTERVENTION

The control group will receive usual care according to the National Board of Health and Welfare guidelines for hypertension treatment.

Interventions

SMS group BEHAVIORAL

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.

SMS group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with hypertension (defined by the International classification of disease Manual ICD-10, diagnose code I10.9)
• years
• Patient must own a smart mobile phone

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University: lead

Study Sites (9)

Bokskogens Health Care Center

Bara, Sweden

Location

Laröds Health Care Center

Helsingborg, Sweden

Location

Vårdcentralen Delfinen

Höganäs, Sweden

Location

Vårdcentralen Nötkärnan

Kållered, Sweden

Location

Nöbbelövs Health Care Center

Lund, Sweden

Location

Rävlanda vårdcentral

Rävlanda, Sweden

Location

Närhälsan Tidaholm

Tidaholm, Sweden

Location

Skärvet Health Care Center

Vaxjo, 35236, Sweden

Location

Hovshaga Health Care Center

Vaxjo, 35261, Sweden

Location

Related Publications (18)

• 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.

  PMID: 27863813 BACKGROUND

• 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.

  PMID: 28919119 BACKGROUND

• 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.

  PMID: 15145106 BACKGROUND

• 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.

  PMID: 19805654 BACKGROUND

• 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.

  PMID: 26654259 BACKGROUND

• 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.

  PMID: 22643153 BACKGROUND

• 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.

  PMID: 23117563 BACKGROUND

• 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.

  PMID: 27095386 BACKGROUND

• 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.

  PMID: 26903176 BACKGROUND

• 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.

  PMID: 26456490 BACKGROUND

• 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.

  PMID: 26393848 BACKGROUND

• 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.

  PMID: 25952653 BACKGROUND

• 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.

  PMID: 10163601 BACKGROUND

• 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.

  PMID: 15367073 BACKGROUND

• 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.

  PMID: 17448248 BACKGROUND

• 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.

  PMID: 21767727 BACKGROUND

• Brodin N, Wolff M, Borgstrom Bolmsjo B, Milos Nymberg V, Nymberg P, Calling S. Factors associated with blood pressure control in Swedish primary care patients with hypertension: a cross-sectional study. Scand J Prim Health Care. 2025 Jun 30:1-9. doi: 10.1080/02813432.2025.2524366. Online ahead of print.

  PMID: 40583484 DERIVED

• Borgstrom Bolmsjo B, Bredfelt J, Calling S, Glock H, Nymberg VM, Bengtsson Bostrom K, Jakobsson U, Nymberg P, Pallon J, Roost M, Wolff M. Health-promoting text messages to patients with hypertension-A randomized controlled trial in Swedish primary healthcare. PLoS One. 2025 Feb 12;20(2):e0314868. doi: 10.1371/journal.pone.0314868. eCollection 2025.

  PMID: 39937817 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: May 29, 2020
• Study Start: September 1, 2020
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data will be approved by a review committee for this purpose.

Locations

SE (9)