Clinical trial NCT02314663: Effectiveness of a Combined Strategy to Improve Therapeutic Compliance and Degree of Control Among Patients With Hypercholesterolaemia
Official title: Effectiveness of a Combined Strategy to Improve Therapeutic Compliance and Degree of Control Among Patients With Hypercholesterolaemia: a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypercholesterolemia
Medication Adherence
Primary Health Care
Keywords: hypercholesterolaemia
medication adherence
primary health care
Lead sponsor: Gerencia de Atención Primaria, Albacete
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2014-12-11
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The proportion of subjects who attain the LDL-C levels set as targets by the Guidelines for Management of Dyslipidaemias and CVR
timeFrame: 24 months
Secondary outcomes:
measure: adherence to lifestyle guidelines and adherence to drug treatment
timeFrame: 24 months
measure: variation in plasma lipid profile levels
timeFrame: 24 months
measure: variation in cardiovascular risk level
timeFrame: 24 months
measure: Occurrence of cardiovascular events
timeFrame: 24 months
measure: determination of the frequency of food consumption
timeFrame: 24 months
measure: smoking habit (answers affirmatively to the question, "Do you smoke?")
timeFrame: 24 months
measure: physical activity (degree of aerobic physical exercise performed (active, partially active or inactive)
timeFrame: 24 months
measure: anthropometric measures (i.e., weight, height, body mass index (BMI), and waist circumference)
timeFrame: 24 months
measure: systolic and diastolic blood pressure
timeFrame: 24 months
measure: degree of satisfaction with the combined strategy ((Likert scale with 5 response options ranging from 1 "very dissatisfied" to 5 "very satisfied")
timeFrame: 24 months
measure: health problems (WONCA ICPC-2 classification)
timeFrame: 24 months
measure: use of hypolipidaemic drug treatment
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Health Care Service of Castilla-La Mancha
name: Ignacio Párraga-Martínez, PhD
role: PRINCIPAL_INVESTIGATOR
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