Text Message Intervention for Prevention of Cardiovascular Disease in Primary Care Patients With Hypertension
NCT ID: NCT03442257
Last Updated: 2019-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
59 participants
INTERVENTIONAL
2018-03-19
2018-12-18
Brief Summary
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Detailed Description
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Persistent hypertension is a key risk factor for coronary heart disease (CHD), stroke and other cardiovascular diseases (CVD), such as heart failure. CVD is, despite a decline in recent decades, still the leading cause of death in Sweden (4). The prevalence of hypertension in adults is around 40% according to a recent multinational study (5). In 30-40% of hypertensive individuals, additional metabolic risk factors such as dyslipidemia, insulin resistance and elevated glucose occur simultaneously, which further multiply the risk for heart disease, diabetes and stroke. An unhealthy lifestyle with physical inactivity and excess energy intake is the major driver of these metabolic risk factors. In most cases lifestyle intervention can reverse or reduce the unfavorable metabolic profile.
Primary healthcare in Sweden is managing the first-line healthcare, offering both prevention and treatment for a majority of chronic diseases. In Sweden, the vast majority of patients with hypertension are treated in primary health care. If the hypertension is well controlled, the GP typically meets the patient once a year for medical checkup, blood tests and medical prescription.
Interventions by SMS-texting have been shown to significantly improve compliance to medications, follow-up rate or disease monitoring.
Trial Design - Randomised clinical trial
Intervention - The experimental treatment will consist of an SMS-intervention addressing metabolic risk factors associated with cardiovascular disorders in patients with hypertension.
After baseline measurement 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 text messages will be developed to support healthy life style changes i.e. regarding general cardiovascular health, tobacco use, physical activity and diet.
Control Treatment - The control group will receive usual care according to the National Board of Health and Welfare guidelines for hypertension treatment.
Recruitment - The participants will be recruited consecutively from three different PHCCs in Skåne. Patients with hypertension will receive information about the study at their annual check-up or other appointment with their GP. If they choose to participate, they will be contacted by phone by a research assistant for additional information, possibility to ask questions about the study, and scheduling a baseline control at their PHCC.
Baseline examination - Included patients that consent to take part in the study will be invited to their PHCC 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 fasting plasma glucose, HbA1c and cholesterol will be drawn in the morning within a few days after the baseline visit.
Randomization- Randomization to study groups will be performed after completion of baseline assessments and questionnaires. A computer generated random number schedule with block sizes of four will be prepared. To assure allocation concealment, the information about group affiliation will be delivered through sealed envelopes.
The research assistant, the patients' GPs, as well as all researchers except Magnus Sandberg (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.
Follow up- Follow up control will be performed after 6 months with the same assessments as at the baseline visit.
Power and sample size - For the pilot study we have assumed that a total number of 60 patients (20 patients per PHCC) will be sufficient to evaluate the feasibility of the intervention and the logistics of the assessments.
For the future full scale study, each group must contain 143 participants. The sample size is based on an assumed statistical power of 80 %, a two-sided test, a significance level of 5 %, a difference of 5 mm Hg between the groups, a standard deviation of 14 mm Hg and a drop out rate of 15 %.
Analysis plan - Data will be analysed according to the Intention-to-treat principle. Differences in mean change of end points between intervention and control groups will be calculated by ANCOVA, with baseline values as covariates.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
SMS
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.
Control
The control group will receive usual care according to the National Board of Health and Welfare guidelines for hypertension treatment.
No interventions assigned to this group
Interventions
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SMS
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.
Eligibility Criteria
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Inclusion Criteria
2. 40 to 80 years of age
3. Patient must own a mobile phone compatible with SMS
Exclusion Criteria
2. Blood pressure at baseline visit ≥180/110 mmHg or systolic blood pressure \<120 mmHg.
3. Serious illness, other than cardiovascular, with short life expectancy (\<1 year)
4. Predicted inability to comply with the study protocol e.g. language difficulties, interpreter needs, serious cognitive impairment.
40 Years
80 Years
ALL
No
Sponsors
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Lund University
OTHER
Responsible Party
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Locations
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Lomma vårdcentral
Lomma, Skåne County, Sweden
Löddeköpinge vårdcentral
Löddeköpinge, Skåne County, Sweden
Sorgenfri vårdcentral
Malmo, Skåne County, Sweden
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Council MR. Developing and evaluating complex interventions: new guidance 2008
Other Identifiers
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2017/674
Identifier Type: -
Identifier Source: org_study_id
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