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

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ClinicalTrials.gov Identifier: NCT02314663
Recruitment Status : Unknown
Verified December 2014 by Gerencia de Atención Primaria, Albacete.
Recruitment status was:  Active, not recruiting
First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Gerencia de Atención Primaria, Albacete

Brief 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.


Condition or disease Intervention/treatment Phase
Hypercholesterolemia Medication Adherence Primary Health Care Device: "COMBINED STRATEGY" Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Combined Strategy to Improve Therapeutic Compliance and Degree of Control Among Patients With Hypercholesterolaemia: a Randomised Clinical Trial
Study Start Date : January 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group

"COMBINED STRATEGY" (a + b + c). Participants in the intervention group will be supplied with: a) "printed matter"; b) "mobile-telephone text messages"; and, c) "self-report cards".

This group receive routine recommendations from their GPs, in accordance with current European clinical practice guidelines on the management of hypercholesterolaemia and cardiovascular risk

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).

No Intervention: Control group
This group receive routine recommendations from their GPs, in accordance with current European clinical practice guidelines on the management of hypercholesterolaemia and cardiovascular risk



Primary Outcome Measures :
  1. The proportion of subjects who attain the LDL-C levels set as targets by the Guidelines for Management of Dyslipidaemias and CVR [ Time Frame: 24 months ]
    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


Secondary Outcome Measures :
  1. adherence to lifestyle guidelines and adherence to drug treatment [ Time Frame: 24 months ]
    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

  2. variation in plasma lipid profile levels [ Time Frame: 24 months ]
    variation in plasma lipid profile levels (total cholesterol, LDL-C, HDL-C and triglycerides

  3. variation in cardiovascular risk level [ Time Frame: 24 months ]
    SCORE and REGICOR tables will be used for the evaluation

  4. Occurrence of cardiovascular events [ Time Frame: 24 months ]
    Ischaemic heart disease, atherothrombotic cerebrovascular disease, heart failure and peripheral artery disease

  5. determination of the frequency of food consumption [ Time Frame: 24 months ]
    determination of the frequency of food consumption

  6. smoking habit (answers affirmatively to the question, "Do you smoke?") [ Time Frame: 24 months ]
    smoking habit, with a smoker being defined as anyone who answers affirmatively to the question, "Do you smoke?"

  7. physical activity (degree of aerobic physical exercise performed (active, partially active or inactive) [ Time Frame: 24 months ]
    physical activity, i.e., determination of the degree of aerobic physical exercise performed (active, partially active or inactive)

  8. anthropometric measures (i.e., weight, height, body mass index (BMI), and waist circumference) [ Time Frame: 24 months ]
    i.e., weight, height, body mass index (BMI), and waist circumference

  9. systolic and diastolic blood pressure [ Time Frame: 24 months ]
    systolic and diastolic blood pressure (two measurements), with the result being the mean of the two results

  10. degree of satisfaction with the combined strategy ((Likert scale with 5 response options ranging from 1 "very dissatisfied" to 5 "very satisfied") [ Time Frame: 24 months ]
    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").

  11. health problems (WONCA ICPC-2 classification) [ Time Frame: 24 months ]
    health problems

  12. use of hypolipidaemic drug treatment [ Time Frame: 24 months ]
    use of hypolipidaemic drug treatment (type of drug and dose)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314663


Sponsors and Collaborators
Gerencia de Atención Primaria, Albacete
Instituto de Salud Carlos III
Investigators
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Principal Investigator: Ignacio Párraga-Martínez, PhD Health Care Service of Castilla-La Mancha

Publications:
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.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gerencia de Atención Primaria, Albacete
ClinicalTrials.gov Identifier: NCT02314663     History of Changes
Other Study ID Numbers: GAPALBACETE
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014
Keywords provided by Gerencia de Atención Primaria, Albacete:
hypercholesterolaemia
medication adherence
primary health care
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases