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

December 9, 2014 updated by: Gerencia de Atención Primaria, Albacete

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

358

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

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
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
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months
variation in plasma lipid profile levels
Time Frame: 24 months
variation in plasma lipid profile levels (total cholesterol, LDL-C, HDL-C and triglycerides
24 months
variation in cardiovascular risk level
Time Frame: 24 months
SCORE and REGICOR tables will be used for the evaluation
24 months
Occurrence of cardiovascular events
Time Frame: 24 months
Ischaemic heart disease, atherothrombotic cerebrovascular disease, heart failure and peripheral artery disease
24 months
determination of the frequency of food consumption
Time Frame: 24 months
determination of the frequency of food consumption
24 months
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?"
24 months
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)
24 months
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
24 months
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
24 months
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").
24 months
health problems (WONCA ICPC-2 classification)
Time Frame: 24 months
health problems
24 months
use of hypolipidaemic drug treatment
Time Frame: 24 months
use of hypolipidaemic drug treatment (type of drug and dose)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gerencia de Atención Primaria, Albacete

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Ignacio Párraga-Martínez, PhD, Health Care Service of Castilla-La Mancha

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

December 4, 2014

First Submitted That Met QC Criteria

December 9, 2014

First Posted (Estimate)

December 11, 2014

Study Record Updates

Last Update Posted (Estimate)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 9, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAPALBACETE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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