Overview

This trial is active, not recruiting.

Conditions hypercholesterolemia, medication adherence, primary health care
Treatment "combined strategy"
Sponsor Gerencia de Atención Primaria, Albacete
Collaborator Instituto de Salud Carlos III
Start date January 2013
End date December 2015
Trial size 358 participants
Trial identifier NCT02314663, GAPALBACETE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
"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
"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)
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 Outcomes

Measure
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

Secondary Outcomes

Measure
adherence to lifestyle guidelines and adherence to drug treatment
time frame: 24 months
variation in plasma lipid profile levels
time frame: 24 months
variation in cardiovascular risk level
time frame: 24 months
Occurrence of cardiovascular events
time frame: 24 months
determination of the frequency of food consumption
time frame: 24 months
smoking habit (answers affirmatively to the question, "Do you smoke?")
time frame: 24 months
physical activity (degree of aerobic physical exercise performed (active, partially active or inactive)
time frame: 24 months
anthropometric measures (i.e., weight, height, body mass index (BMI), and waist circumference)
time frame: 24 months
systolic and diastolic blood pressure
time frame: 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
health problems (WONCA ICPC-2 classification)
time frame: 24 months
use of hypolipidaemic drug treatment
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Effectiveness of a Combined Strategy to Improve Therapeutic Compliance and Degree of Control Among Patients With Hypercholesterolaemia: a Randomised Clinical Trial
Principal investigator Ignacio Párraga-Martínez, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Gerencia de Atención Primaria, Albacete.