Effectiveness of a Combined Strategy to Improve Therapeutic Compliance and Degree of Control Among Patients With Hypercholesterolaemia

Hypercholesterolemia Clinical Trial

— EFESCOM  

Official title:

Effectiveness of a Combined Strategy to Improve Therapeutic Compliance and Degree of Control Among Patients With Hypercholesterolaemia: a Randomised Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02314663
• Other study ID #: GAPALBACETE
• Status: Active, not recruiting
• Phase: N/A
• First received: December 4, 2014
• Last updated: December 9, 2014
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: Gerencia de Atención Primaria, Albacete
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministerio de Sanidad, Servicios Sociales e IgualdadSpain: Servicio de Salud de Castilla-La Mancha
• Study type: Interventional

Clinical Trial Summary

Background In subjects with hypercholesterolaemia, cholesterol values remain above guideline levels. One of the limiting factors to the achievement of goals in such patients is therapeutic non-adherence. The aim of this study is to assess the effectiveness of an intervention designed to improve control of hypercholesterolaemic patients, consisting of a combined strategy that would include the delivery of printed information, treatment-compliance check cards and the dispatch of text messages as complementary measures in support of the intervention at the general practitioner's practice.

Methods/Design A randomised, parallel-group clinical trial will be conducted at the family medicine outpatient facilities of eight health centres in three of Spain's Autonomous Regions, covering a total of 358 subjects aged 18 years or over with diagnosis of hypercholesterolaemia. Patients in the intervention group will be supplied with printed material with information on the disease and its management, mobile-telephone text messages with guideline summaries, reminders of forthcoming appointments and/or arrangements for making new appointments in the event of non-attendance, and self-report cards to check compliance with recommendations. Both groups -intervention and control- will receive routine recommendations from their physicians in accordance with current European clinical practice guidelines for hypercholesterolaemia and cardiovascular risk management. As regards the measurements to be made, the main variable is the proportion of subjects who attain the low density lipoprotein cholesterol levels set as a target across a follow-up period of 24 months. The secondary variables are as follows: adherence to recommendations on lifestyle and adherence to drug treatment; variation in lipid profiles and cardiovascular risk levels; appearance of cardiovascular events; physical activity; food consumption; smoking habit; anthropometric measures; blood pressure; health problems; use of hypolipidaemic agents; socio-demographic data; beliefs and expectations about preventive recommendations; and degree of satisfaction with the combined strategy.

Discussion Should this intervention prove effective, a recommendation could be issued on the application of this combined strategy to subjects with hypercholesterolaemia. It is a simple, relatively inexpensive intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 358
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• be diagnosed with hypercholesterolaemia, as defined according to the criteria stipulated in the cardiovascular prevention guidelines of the 2009 Prevention Activities and Promotion of Health Programme (total cholesterol of 250 mg/dl or higher).

• be patients aged 18 years or over attending any of the participating health centres.

Exclusion Criteria:

• any person hindered from participating in the follow-up of the proposed intervention, e.g., illiterate subjects and non-users of mobile telephones.

• any person with a physical disability or impairment which prevents him/her from attending the follow-up visits.

• any person suffering from a significant chronic organic or psychiatric disease.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia
• Medication Adherence
• Primary Health Care

Intervention

Device:
• "COMBINED STRATEGY"
Participants in the intervention group will be supplied with: a) "printed matter" containing information on the disease and its management (this will be handed out at each of the follow-up visits); b) "mobile-telephone text messages" containing guideline summaries, reminders of forthcoming appointments and/or arrangements for making new appointments in the event of non-attendance (in the periods between visits); and, c) "self-report cards" to check compliance with recommendations (across the entire follow-up).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Albacete	Instituto de Salud Carlos III

References & Publications (13)

Banegas JR, López-García E, Dallongeville J, Guallar E, Halcox JP, Borghi C, Massó-González EL, Jiménez FJ, Perk J, Steg PG, De Backer G, Rodríguez-Artalejo F. Achievement of treatment goals for primary prevention of cardiovascular disease in clinical practice across Europe: the EURIKA study. Eur Heart J. 2011 Sep;32(17):2143-52. doi: 10.1093/eurheartj/ehr080. Epub 2011 Apr 6. — View Citation

Bermingham M, Hayden J, Dawkins I, Miwa S, Gibson D, McDonald K, Ledwidge M. Prospective analysis of LDL-C goal achievement and self-reported medication adherence among statin users in primary care. Clin Ther. 2011 Sep;33(9):1180-9. doi: 10.1016/j.clinthera.2011.07.007. Epub 2011 Aug 12. — View Citation

De Geest S, Sabaté E. Adherence to long-term therapies: evidence for action. Eur J Cardiovasc Nurs. 2003 Dec;2(4):323. — View Citation

European Association for Cardiovascular Prevention & Rehabilitation, Reiner Z, Catapano AL, De Backer G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Filardi PP, Riccardi G, Storey RF, Wood D; ESC Committee for Practice Guidelines (CPG) 2008-2010 and 2010-2012 Committees. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011 Jul;32(14):1769-818. doi: 10.1093/eurheartj/ehr158. Epub 2011 Jun 28. — View Citation

Haynes RB, McKibbon KA, Kanani R, Brouwers C, Oliver T: Interventions to assist patients to follow prescriptions for medications. In: Cochrane Collaboration: Cochrane Library. Oxford: Update Software, 1998.

Kotseva K, Wood D, De Backer G, De Bacquer D, Pyörälä K, Keil U; EUROASPIRE Study Group. Cardiovascular prevention guidelines in daily practice: a comparison of EUROASPIRE I, II, and III surveys in eight European countries. Lancet. 2009 Mar 14;373(9667):929-40. doi: 10.1016/S0140-6736(09)60330-5. — View Citation

Kotseva K, Wood D, De Backer G, De Bacquer D, Pyörälä K, Keil U; EUROASPIRE Study Group. EUROASPIRE III: a survey on the lifestyle, risk factors and use of cardioprotective drug therapies in coronary patients from 22 European countries. Eur J Cardiovasc Prev Rehabil. 2009 Apr;16(2):121-37. doi: 10.1097/HJR.0b013e3283294b1d. — View Citation

Márquez Contreras E, Casado Martínez JJ, Corchado Albalat Y, Chaves González R, Grandío A, Losada Velasco C, Obando J, de Eugenio JM, Barrera JM. [Efficacy of an intervention to improve treatment compliance in hyperlipidemias]. Aten Primaria. 2004 May 15;33(8):443-50. Spanish. — View Citation

Marrugat J, Solanas P, D'Agostino R, Sullivan L, Ordovas J, Cordón F, Ramos R, Sala J, Masià R, Rohlfs I, Elosua R, Kannel WB. [Coronary risk estimation in Spain using a calibrated Framingham function]. Rev Esp Cardiol. 2003 Mar;56(3):253-61. Spanish. — View Citation

McDonald HP, Garg AX, Haynes RB. Interventions to enhance patient adherence to medication prescriptions: scientific review. JAMA. 2002 Dec 11;288(22):2868-79. Review. Erratum in: JAMA. 2003 Jun 25;289(24):3242. — View Citation

Perk J, De Backer G, Gohlke H, Graham I, Reiner Z, Verschuren M, Albus C, Benlian P, Boysen G, Cifkova R, Deaton C, Ebrahim S, Fisher M, Germano G, Hobbs R, Hoes A, Karadeniz S, Mezzani A, Prescott E, Ryden L, Scherer M, Syvänne M, Scholte op Reimer WJ, Vrints C, Wood D, Zamorano JL, Zannad F; European Association for Cardiovascular Prevention & Rehabilitation (EACPR); ESC Committee for Practice Guidelines (CPG). European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Eur Heart J. 2012 Jul;33(13):1635-701. doi: 10.1093/eurheartj/ehs092. Epub 2012 May 3. Erratum in: Eur Heart J. 2012 Sep;33(17):2126. — View Citation

Vegazo O, Banegas JR, Civeira F, Serrano Aisa PL, Jiménez FJ, Luengo E; Estudio HISPALIPID. [Prevalence of dyslipidemia in outpatients of the Spanish health service: the HISPALIPID Study]. Med Clin (Barc). 2006 Sep 9;127(9):331-4. Spanish. — View Citation

Waters DD, Brotons C, Chiang CW, Ferrières J, Foody J, Jukema JW, Santos RD, Verdejo J, Messig M, McPherson R, Seung KB, Tarasenko L; Lipid Treatment Assessment Project 2 Investigators. Lipid treatment assessment project 2: a multinational survey to evaluate the proportion of patients achieving low-density lipoprotein cholesterol goals. Circulation. 2009 Jul 7;120(1):28-34. doi: 10.1161/CIRCULATIONAHA.108.838466. Epub 2009 Jun 22. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects who attain the LDL-C levels set as targets by the Guidelines for Management of Dyslipidaemias and CVR	The main study variable is the proportion of subjects who attain the LDL-C levels set as targets by the Guidelines for Management of Dyslipidaemias and CVR, across a follow-up period of 24 months. The plasma values taken as cardiovascular prevention targets are: a) LDL-C <100 mg/dl for patients without established cardiovascular disease or diabetes mellitus; and, b) LDL-C <70 mg/dl for patients with diabetes mellitus or established cardiovascular disease	24 months	No
Secondary	adherence to lifestyle guidelines and adherence to drug treatment	adherence to lifestyle guidelines and adherence to drug treatment, as seen from self-reported adherence (adapted Haynes-Sackett test), validated questionnaire (Morisky-Green test) and Likert scale with 5 response options	24 months	No
Secondary	variation in plasma lipid profile levels	variation in plasma lipid profile levels (total cholesterol, LDL-C, HDL-C and triglycerides	24 months	No
Secondary	variation in cardiovascular risk level	SCORE and REGICOR tables will be used for the evaluation	24 months	No
Secondary	Occurrence of cardiovascular events	Ischaemic heart disease, atherothrombotic cerebrovascular disease, heart failure and peripheral artery disease	24 months	No
Secondary	determination of the frequency of food consumption	determination of the frequency of food consumption	24 months	No
Secondary	smoking habit (answers affirmatively to the question, "Do you smoke?")	smoking habit, with a smoker being defined as anyone who answers affirmatively to the question, "Do you smoke?"	24 months	No
Secondary	physical activity (degree of aerobic physical exercise performed (active, partially active or inactive)	physical activity, i.e., determination of the degree of aerobic physical exercise performed (active, partially active or inactive)	24 months	No
Secondary	anthropometric measures (i.e., weight, height, body mass index (BMI), and waist circumference)	i.e., weight, height, body mass index (BMI), and waist circumference	24 months	No
Secondary	systolic and diastolic blood pressure	systolic and diastolic blood pressure (two measurements), with the result being the mean of the two results	24 months	No
Secondary	degree of satisfaction with the combined strategy ((Likert scale with 5 response options ranging from 1 "very dissatisfied" to 5 "very satisfied")	degree of satisfaction with the combined strategy according to a satisfaction questionnaire (Likert scale with 5 response options ranging from 1 "very dissatisfied" to 5 "very satisfied").	24 months	No
Secondary	health problems (WONCA ICPC-2 classification)	health problems	24 months	No
Secondary	use of hypolipidaemic drug treatment	use of hypolipidaemic drug treatment (type of drug and dose)	24 months	No