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

Gerencia de Atención Primaria, Albacete

Status: Unknown

Conditions: Medication Adherence; Hypercholesterolemia; Primary Health Care

Treatments: Device: "COMBINED STRATEGY"

Study type: Interventional

Funder types: Other

Identifiers

NCT02314663

GAPALBACETE

Details and patient eligibility

About

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.

Enrollment: 358 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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358 participants in 2 patient groups

Intervention group

Experimental group

Description:

"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

Treatment:

Device: "COMBINED STRATEGY"

Control group

No Intervention group

Description:

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