Text Message Intervention for Prevention of Cardiovascular Disease in Primary Care Patients With Hypertension

NCT03442257 | Completed

• 1 other identifier: 2017/674
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypertension; Cardiovascular Risk Factor

Keywords

Hypertension; Text Messaging; Primary Prevention; Cardiovascular Risk Factor; Primary Health Care; Health Promotion

Outcome Measures

Primary Outcomes (1)

• Change in blood pressure

  Measured by automated devices (mmHg)

  Six months

Secondary Outcomes (10)

• 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 BMI

  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

Control

NO INTERVENTION

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

Interventions

SMS BEHAVIORAL

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.

SMS group

Eligibility Criteria

• Age: 40 Years - 80 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).
• to 80 years of age
• Patient must own a mobile phone compatible with SMS

You may not qualify if:

• 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)
• Blood pressure at baseline visit ≥180/110 mmHg or systolic blood pressure \<120 mmHg.
• Serious illness, other than cardiovascular, with short life expectancy (\<1 year)
• Predicted inability to comply with the study protocol e.g. language difficulties, interpreter needs, serious cognitive impairment.

Sponsors & Collaborators

• Lund University: lead

Study Sites (3)

Lomma vårdcentral

Lomma, Skåne County, 23434, Sweden

Location

Löddeköpinge vårdcentral

Löddeköpinge, Skåne County, 24630, Sweden

Location

Sorgenfri vårdcentral

Malmo, Skåne County, 214 33, Sweden

Location

Related Publications (10)

• 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

• Chow CK, Teo KK, Rangarajan S, Islam S, Gupta R, Avezum A, Bahonar A, Chifamba J, Dagenais G, Diaz R, Kazmi K, Lanas F, Wei L, Lopez-Jaramillo P, Fanghong L, Ismail NH, Puoane T, Rosengren A, Szuba A, Temizhan A, Wielgosz A, Yusuf R, Yusufali A, McKee M, Liu L, Mony P, Yusuf S; PURE (Prospective Urban Rural Epidemiology) Study investigators. Prevalence, awareness, treatment, and control of hypertension in rural and urban communities in high-, middle-, and low-income countries. JAMA. 2013 Sep 4;310(9):959-68. doi: 10.1001/jama.2013.184182.

  PMID: 24002282 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

• 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

• Lin H, Wu X. Intervention strategies for improving patient adherence to follow-up in the era of mobile information technology: a systematic review and meta-analysis. PLoS One. 2014 Aug 6;9(8):e104266. doi: 10.1371/journal.pone.0104266. eCollection 2014.

  PMID: 25100267 BACKGROUND

• Krishna S, Boren SA, Balas EA. Healthcare via cell phones: a systematic review. Telemed J E Health. 2009 Apr;15(3):231-40. doi: 10.1089/tmj.2008.0099.

  PMID: 19382860 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

• Wolff M, Sundquist K, Larsson Lonn S, Midlov P. Impact of yoga on blood pressure and quality of life in patients with hypertension - a controlled trial in primary care, matched for systolic blood pressure. BMC Cardiovasc Disord. 2013 Dec 7;13:111. doi: 10.1186/1471-2261-13-111.

  PMID: 24314119 BACKGROUND

• Vickers AJ, Altman DG. Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001 Nov 10;323(7321):1123-4. doi: 10.1136/bmj.323.7321.1123. No abstract available.

  PMID: 11701584 BACKGROUND

Related Links

• Council MR. Developing and evaluating complex interventions: new guidance 2008

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
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: February 22, 2018
• Study Start: March 19, 2018
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: February 15, 2019

Record last verified: 2018-02

Locations

SE (3)