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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypercholesterolemia, Medication Adherence, Primary Health Care

Intervention / Treatment
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* Device: COMBINED STRATEGY


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 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).<br>|
| No Intervention: Control group<br>This group receive routine recommendations from their GPs, in accordance with current European clinical practice guidelines on the management of hypercholesterolaemia and cardiovascular risk | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| variation in plasma lipid profile levels | variation in plasma lipid profile levels (total cholesterol, LDL-C, HDL-C and triglycerides | 24 months | 
| variation in cardiovascular risk level | SCORE and REGICOR tables will be used for the evaluation | 24 months | 
| Occurrence of cardiovascular events | Ischaemic heart disease, atherothrombotic cerebrovascular disease, heart failure and peripheral artery disease | 24 months | 
| determination of the frequency of food consumption | determination of the frequency of food consumption | 24 months | 
| 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 | 
| 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 | 
| 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 | 
| systolic and diastolic blood pressure | systolic and diastolic blood pressure (two measurements), with the result being the mean of the two results | 24 months | 
| 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 | 
| health problems (WONCA ICPC-2 classification) | health problems | 24 months | 
| use of hypolipidaemic drug treatment | use of hypolipidaemic drug treatment (type of drug and dose) | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypercholesterolaemia, medication adherence, primary health care