A cluster randomized controlled protocol for Check and Support study

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1 A cluster romized controlled protocol for Check Support study Aapo Tahkola, Health Centre of Jyväskylä Co-operation Area University of Eastern Finl Hannu Kautiainen, Medcare Oy Päivi Korhonen, University of Turku Teemu Niiranen, National Institute for Health Welfare Pekka Mäntyselkä, University of Eastern Finl, Institute of Public Health Clinical Nutrition

2 Aims 1. To test the efficacy of personalized SMS-text message support check-list for initiation of for better blood pressure control at 12 months 2. To enhance our knowledge of hypertension treatment in Finnish primary care

3 Background: Hypertension High blood pressure (BP) is globally the leading risk factor for cardiovascular related diseases 1 Usual BP is strongly related to vascular overall mortality 2 Pharmacological BP reduction by 10/5 mmhg in persons with hypertension decreases strokes by 30 40% severe cardiovascular events by 16 % in 5 years 3,4,5 1. Lim SS, Vos T, Flaxman AD, et al. A comparative risk assessment of burden of disease injury attributable to 67 risk factors risk factor clusters in 21 regions, : A systematic analysis for the global burden of disease study Lancet. 2012;380(9859): Lewington S, Clarke R, Qizilbash N, Peto R, Collins R, Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: A meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002;360(9349): Collins R, Peto R, MacMahon S, et al. Blood pressure, stroke, coronary heart disease. part 2, short-term reductions in blood pressure: Overview of romised drug trials in their epidemiological context. Lancet. 1990;335(8693): Collins R, MacMahon S. Blood pressure, antihypertensive drug treatment the risks of stroke of coronary heart disease. Br Med Bull. 1994;50(2): Lawes CM, Bennett DA, Feigin VL ym. Blood pressure stroke: an overview of published reviews. Stroke 2004;35: «PMID: »PubMed

4 Background: Failure in treatment Most of the patients with antihypertensive do not achieve the BP target in Finl 6 worldwide 7 Poor adherence is the most important factor in failing to control hypertension 8 Even half of patients quit the during the first year 9 6. Varis J, Savola H, Vesalainen R, Kantola I. Treatment of hypertension in finnish general practice seems unsatisfactory despite evidence-based guidelines. Blood Press. 2009;18(1-2): Costa FV. Compliance with antihypertensive treatment. Clin Exp Hypertens. 1996;18(3-4): The sixth report of the hoint national committee on prevention, detection, evaluation, treatment of high blood pressure. Bethesda, MD, National High Blood Pressure Education Program, National Heart, Lung, Blood Institute, National Institutes of Health Flack JM, Novikov SV, Ferrario CM. Benefits of adherence to anti-hypertensive drug therapy. Eur Heart J. 1996;17 Suppl A:16-20.

Kaplan Meier plots of the time course of adherence parameters of 36 907 patients prescribed oral s for one of a variety of medical conditions in 95 studies during the first

5 Kaplan Meier plots of the time course of adherence parameters of patients prescribed oral s for one of a variety of medical conditions in 95 studies during the first year of electronic compilation of the patients dosing histories. Michel Burnier et al. Hypertension. 2013;62: Copyright American Heart Association, Inc. All rights reserved.

6 Background: Other elements Changeable reasons for the failure in treatment forgetting the 10,11 lack of motivation or 12 misconceptions about 13,14 doctors do not take action when recognizing nonoptimal treatment Khatib R, Schwalm JD, Yusuf S, Haynes RB, McKee M, Khan M, Nieuwlaat R Patient healthcare provider barriers to hypertension awareness, treatment follow up: a systematic review meta-analysis of qualitative quantitative studies.. PLoS One Jan 15;9(1):e doi: /journal.pone ecollection 2014 Jan Meriranta P. Kohonneen verenpaineen hoito, hyvää hoitoa etsimässä. Väitöskirja, Kuopion yliopisto Jokisalo E.Compliance patient-perceived problems in the treatment of hypertension. Doctoral dissertation Unsiversity of Kuopio. 13. Pound P, Britten N, Morgan M, ym. Resisting medicines: a synthesis of qualitative studies of medicine taking. Soc Sci Med 2005;61: Oliveria SA1, Lapuerta P, McCarthy BD, L'Italien GJ, Berlowitz DR, Asch SM. Physician-related barriers to the effective management of uncontrolled hypertension.arch Intern Med Feb 25;162(4): Inkster, M., Montgomery, A., Donnan, P., MacDonald, T., Sullivan, F. & Fahey, T. Organisational factors in relation to control of blood pressure: an observational study. Br J Gen Pract 2005 Dec;55(521):931-7.

7 Background: Other elements Associated with succesful treatment knowing the blood pressure target 11 good patient-doctor relationship, simple, understing hypertension patient s active role in monitoring disease 16, Sabaté E. Adherence to Long-term Therapies. Evidence for Action. Geneva: World Health Organization, Glynn LG1, Murphy AW, Smith SM, Schroeder K, Fahey T. Interventions used to improve control of blood pressure in patients with hypertension. Cochrane Database Syst Rev Mar17;(3):CD doi: / CD pub4.

8 How to improve adherence treating to target? We are still missing an intervention 1. Effective 2. Simple 3. Low cost enough to be implemented wide-scale in non-research settings 16, Kripalani S, Yao X, Haynes RB. Interventions to enhance adherence in chronic medical conditions: A systematic review. Arch Intern Med. 2007;167(6): Nieuwlaat R, Wilczynski N, Navarro T, et al. Interventions for enhancing adherence. Cochrane Database Syst Rev. 2014;11:CD

9 Methods 8 study centers Romising Screening Control group: Intervention group: Base line assessment + valid device for home measurements Follow-up assessment at 12 months - Eligibility confirmed informed consent obtained - Office blood pressure home blood pressure (if available) - Demographics, BMI, waist circumference, laboratory tests ECG - Questionnaires: AUDIT-C, EQ-5D-5L, Exercising habits, Heaviness of smoking index participants starting the first antihypertensive participants starting the first antihypertensive Check list for initiation SMS text message support - Office blood pressure home blood pressure - Medication Adherence: MMAS-8 electric pharmacy refill data (MPR) - BMI, waist circumference - Laboratory tests ECG - Questionnaires: AUDIT-C, EQ-5D-5L, Exercising habits, Heaviness of smoking index - Hypertension-related use of health care services - Setting (physicians) knowing (participants) an adequate BP target

10 Methods 8 study centers Romising Screening Control group: Intervention group: Base line assessment + valid device for home measurements Follow-up assessment at 12 months - Eligibility confirmed informed consent obtained - Office blood pressure home blood pressure (if available) - Demographics, BMI, waist circumference, laboratory tests ECG - Questionnaires: AUDIT-C, EQ-5D-5L, Exercising habits, Heaviness of smoking index participants starting the first antihypertensive participants starting the first antihypertensive Check list for initiation SMS text message support - Office blood pressure home blood pressure - Medication Adherence: MMAS-8 electric pharmacy refill data (MPR) - BMI, waist circumference - Laboratory tests ECG - Questionnaires: AUDIT-C, EQ-5D-5L, Exercising habits, Heaviness of smoking index - Hypertension-related use of health care services - Setting (physicians) knowing (participants) an adequate BP target

11 Participants primary care patients aged years with 1. a clinical diagnosis of hypertension 2. a mobile phone 3. ability to read text messages 4. ability to master personal 5. ability to perform home BP measurements 6. agreement in using electric drug prescription, about to start for hypertension for the first time

12 Exclusion criteria 1. having or is suspected to have depression or psychosis 2. serious malignant disease, which is evaluated to have an impact on life expectancy 3. atrial flutter or atrial fibrillation 4. previous history of medical treatment of hypertension 5. pregnancy 6. not willing to give informed consent take part in the study 7. systolic BP more than 200 mmhg, diastolic BP more than 120 mmhg 8. sudden onset or worsening of hypertension 9. hypokalemia 10.clinical signs of kidney disease: proteinuria (U-alb/krea >30 mg/mmol) or glomerulus filtration rate (egfr) less than 45 ml/min or hypokalemia

13 Methods 8 study centers Romising Screening Control group: Intervention group: Base line assessment + valid device for home measurements Follow-up assessment at 12 months - Eligibility confirmed informed consent obtained - Office blood pressure home blood pressure (if available) - Demographics, BMI, waist circumference, laboratory tests ECG - Questionnaires: AUDIT-C, EQ-5D-5L, Exercising habits, Heaviness of smoking index participants starting the first antihypertensive participants starting the first antihypertensive Check list for initiation SMS text message support - Office blood pressure home blood pressure - Medication Adherence: MMAS-8 electric pharmacy refill data (MPR) - BMI, waist circumference - Laboratory tests ECG - Questionnaires: AUDIT-C, EQ-5D-5L, Exercising habits, Heaviness of smoking index - Hypertension-related use of health care services - Setting (physicians) knowing (participants) an adequate BP target

14 Methods 8 study centers Romising Screening Control group: Intervention group: Base line assessment + valid device for home measurements Follow-up assessment at 12 months - Eligibility confirmed informed consent obtained - Office blood pressure home blood pressure (if available) - Demographics, BMI, waist circumference, laboratory tests ECG - Questionnaires: AUDIT-C, EQ-5D-5L, Exercising habits, Heaviness of smoking index participants starting the first antihypertensive participants starting the first antihypertensive Check list for initiation SMS text message support - Office blood pressure home blood pressure - Medication Adherence: MMAS-8 electric pharmacy refill data (MPR) - BMI, waist circumference - Laboratory tests ECG - Questionnaires: AUDIT-C, EQ-5D-5L, Exercising habits, Heaviness of smoking index - Hypertension-related use of health care services - Setting (physicians) knowing (participants) an adequate BP target

15 Methods 8 study centers Romising Screening Control group: Intervention group: Base line assessment + valid device for home measurements Follow-up assessment at 12 months - Eligibility confirmed informed consent obtained - Office blood pressure home blood pressure (if available) - Demographics, BMI, waist circumference, laboratory tests ECG - Questionnaires: AUDIT-C, EQ-5D-5L, Exercising habits, Heaviness of smoking index participants starting the first antihypertensive participants starting the first antihypertensive Check list for initiation SMS text message support - Office blood pressure home blood pressure - Medication Adherence: MMAS-8 electric pharmacy refill data (MPR) - BMI, waist circumference - Laboratory tests ECG - Questionnaires: AUDIT-C, EQ-5D-5L, Exercising habits, Heaviness of smoking index - Hypertension-related use of health care services - Setting (physicians) knowing (participants) an adequate BP target

16 Methods 8 study centers Romising Screening Control group: Intervention group: Base line assessment + Valid device for home measurements Follow-up assessment at 12 months - Eligibility confirmed informed consent obtained - Office blood pressure home blood pressure (if available) - Demographics, BMI, waist circumference, laboratory tests ECG - Questionnaires: AUDIT-C, EQ-5D-5L, Exercising habits, Heaviness of smoking index participants starting the first antihypertensive participants starting the first antihypertensive Check list for initiation SMS text message support - Office blood pressure home blood pressure - Medication Adherence: MMAS-8 electric pharmacy refill data (MPR) - BMI, waist circumference - Laboratory tests ECG - Questionnaires: AUDIT-C, EQ-5D-5L, Exercising habits, Heaviness of smoking index - Hypertension-related use of health care services - Setting (physicians) knowing (participants) an adequate BP target

17 Target Why to treat? Check list for initiation Motivation level Choice of + Documents SMS support Something unclear? Setting 1. check point

18 Methods 8 study centers Romising Screening Control group: Intervention group: Base line assessment + Valid device for home measurements Follow-up assessment at 12 months - Eligibility confirmed informed consent obtained - Office blood pressure home blood pressure (if available) - Demographics, BMI, waist circumference, laboratory tests ECG - Questionnaires: AUDIT-C, EQ-5D-5L, Exercising habits, Heaviness of smoking index participants starting the first antihypertensive participants starting the first antihypertensive Check list for initiation SMS text message support - Office blood pressure home blood pressure - Medication Adherence: MMAS-8 electric pharmacy refill data (MPR) - BMI, waist circumference - Laboratory tests ECG - Questionnaires: AUDIT-C, EQ-5D-5L, Exercising habits, Heaviness of smoking index - Hypertension-related use of health care services - Setting (physicians) knowing (participants) an adequate BP target

19 SMS text message support intensifying loop if not in target 2 ~4 52 weeks Onset of Recommended first control (phone call) When in target End of follow up SMS: Intensive period SMS: When in target daily reminders for two weeks coping with coping with adverse effects performing adequate self-monitoring preparing to clinical appointment less often reminders of importance of treatment behavioral changes keeping up with performing adequate selfmonitoring preparing attending to clinical appointment at 12 months

20 Hello! Did you already pick up the from the pharmacy? If not, we recommend to take action today! With text messages we help you to succesful treatment to achieve your blood pressure target < 135/85 mmhg. Let s take care that you achieve both systolic diastolic target! More information about your in your Guide for or

21 Methods 8 study centers Romising Screening Control group: Intervention group: Base line assessment + Valid device for home measurements Follow-up assessment at 12 months - Eligibility confirmed informed consent obtained - Office blood pressure home blood pressure (if available) - Demographics, BMI, waist circumference, laboratory tests ECG - Questionnaires: AUDIT-C, EQ-5D-5L, Exercising habits, Heaviness of smoking index participants starting the first antihypertensive participants starting the first antihypertensive Check list for initiation SMS text message support - Office blood pressure home blood pressure - Medication Adherence: MMAS-8 electric pharmacy refill data (MPR) - BMI, waist circumference - Laboratory tests ECG - Questionnaires: AUDIT-C, EQ-5D-5L, Exercising habits, Heaviness of smoking index - Hypertension-related use of health care services - Setting (physicians) knowing (participants) an adequate BP target

22 Outcomes Primary the proportion of patients achieving the systolic BP target at 12-months Secondary the proportion of patients well adherent to change in office BP home BP Additional hypertension-related use of health care services, hypertension-related blood tests ECG changes, BMI, waist circumference, exercising habits, smoking, alcohol use, perceived quality of life at base line at 12-month, setting (physicians) knowing (participants) an adequate BP target

23 At the moment Recruiting Target: All patients recruited in 2015

24 Thank you! Contact information: Aapo Tahkola,

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