HypercholesterolemiaEFESCOMNCT02314663
Effectiveness of a Combined Strategy to Improve Therapeutic Compliance and Degree of Control Among Patients With Hypercholesterolaemia
A study testing "COMBINED STRATEGY" in people with Hypercholesterolemia and Medication Adherence, run by Gerencia de Atención Primaria, Albacete.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia, Medication Adherence, Primary Health Care
- What is being tested?
- "COMBINED STRATEGY"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Being tested
- "COMBINED STRATEGY"
- Keywords
- hypercholesterolaemia, medication adherence, primary health care
- Medical subject headings
- Hypercholesterolemia, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"COMBINED STRATEGY"Device
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | 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 Receives: Device: "COMBINED STRATEGY" |
| Control group | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (12)
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
Measured: 24 months
variation in plasma lipid profile levels
variation in plasma lipid profile levels (total cholesterol, LDL-C, HDL-C and triglycerides
Measured: 24 months
variation in cardiovascular risk level
SCORE and REGICOR tables will be used for the evaluation
Measured: 24 months
Occurrence of cardiovascular events
Ischaemic heart disease, atherothrombotic cerebrovascular disease, heart failure and peripheral artery disease
Measured: 24 months
determination of the frequency of food consumption
determination of the frequency of food consumption
Measured: 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?"
Measured: 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)
Measured: 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
Measured: 24 months
systolic and diastolic blood pressure
systolic and diastolic blood pressure (two measurements), with the result being the mean of the two results
Measured: 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").
Measured: 24 months
health problems (WONCA ICPC-2 classification)
health problems
Measured: 24 months
use of hypolipidaemic drug treatment
use of hypolipidaemic drug treatment (type of drug and dose)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Albacete
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Ignacio Párraga-Martínez, PhD, Principal investigator, Health Care Service of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314663
- Sponsor's protocol ID
- GAPALBACETE
- Acronym
- EFESCOM
- Status last verified
- Dec 2014
- First submitted
- 4 Dec 2014
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
European Association for Cardiovascular Prevention & Rehabilitation; Reiner Z, Catapano AL, De Backer G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Filardi PP, Riccardi G, Storey RF, Wood D; ESC Committee for Practice Guidelines (CPG) 2008-2010 and 2010-2012 Committees. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011 Jul;32(14):1769-818. doi: 10.1093/eurheartj/ehr158. Epub 2011 Jun 28.
PubMed 21712404Kotseva K, Wood D, De Backer G, De Bacquer D, Pyorala K, Keil U; EUROASPIRE Study Group. Cardiovascular prevention guidelines in daily practice: a comparison of EUROASPIRE I, II, and III surveys in eight European countries. Lancet. 2009 Mar 14;373(9667):929-40. doi: 10.1016/S0140-6736(09)60330-5.
PubMed 19286092Vegazo O, Banegas JR, Civeira F, Serrano Aisa PL, Jimenez FJ, Luengo E; Estudio HISPALIPID. [Prevalence of dyslipidemia in outpatients of the Spanish health service: the HISPALIPID Study]. Med Clin (Barc). 2006 Sep 9;127(9):331-4. doi: 10.1157/13092314. Spanish.
PubMed 16987452Marrugat J, Solanas P, D'Agostino R, Sullivan L, Ordovas J, Cordon F, Ramos R, Sala J, Masia R, Rohlfs I, Elosua R, Kannel WB. [Coronary risk estimation in Spain using a calibrated Framingham function]. Rev Esp Cardiol. 2003 Mar;56(3):253-61. doi: 10.1016/s0300-8932(03)76861-4. Spanish.
PubMed 12622955Perk J, De Backer G, Gohlke H, Graham I, Reiner Z, Verschuren M, Albus C, Benlian P, Boysen G, Cifkova R, Deaton C, Ebrahim S, Fisher M, Germano G, Hobbs R, Hoes A, Karadeniz S, Mezzani A, Prescott E, Ryden L, Scherer M, Syvanne M, Scholte op Reimer WJ, Vrints C, Wood D, Zamorano JL, Zannad F; European Association for Cardiovascular Prevention & Rehabilitation (EACPR); ESC Committee for Practice Guidelines (CPG). European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Eur Heart J. 2012 Jul;33(13):1635-701. doi: 10.1093/eurheartj/ehs092. Epub 2012 May 3. No abstract available.
PubMed 22555213Kotseva K, Wood D, De Backer G, De Bacquer D, Pyorala K, Keil U; EUROASPIRE Study Group. EUROASPIRE III: a survey on the lifestyle, risk factors and use of cardioprotective drug therapies in coronary patients from 22 European countries. Eur J Cardiovasc Prev Rehabil. 2009 Apr;16(2):121-37. doi: 10.1097/HJR.0b013e3283294b1d.
PubMed 19287307Waters DD, Brotons C, Chiang CW, Ferrieres J, Foody J, Jukema JW, Santos RD, Verdejo J, Messig M, McPherson R, Seung KB, Tarasenko L; Lipid Treatment Assessment Project 2 Investigators. Lipid treatment assessment project 2: a multinational survey to evaluate the proportion of patients achieving low-density lipoprotein cholesterol goals. Circulation. 2009 Jul 7;120(1):28-34. doi: 10.1161/CIRCULATIONAHA.108.838466. Epub 2009 Jun 22.
PubMed 19546386Bermingham M, Hayden J, Dawkins I, Miwa S, Gibson D, McDonald K, Ledwidge M. Prospective analysis of LDL-C goal achievement and self-reported medication adherence among statin users in primary care. Clin Ther. 2011 Sep;33(9):1180-9. doi: 10.1016/j.clinthera.2011.07.007. Epub 2011 Aug 12.
PubMed 21840055De Geest S, Sabate E. Adherence to long-term therapies: evidence for action. Eur J Cardiovasc Nurs. 2003 Dec;2(4):323. doi: 10.1016/S1474-5151(03)00091-4. No abstract available.
PubMed 14667488Banegas JR, Lopez-Garcia E, Dallongeville J, Guallar E, Halcox JP, Borghi C, Masso-Gonzalez EL, Jimenez FJ, Perk J, Steg PG, De Backer G, Rodriguez-Artalejo F. Achievement of treatment goals for primary prevention of cardiovascular disease in clinical practice across Europe: the EURIKA study. Eur Heart J. 2011 Sep;32(17):2143-52. doi: 10.1093/eurheartj/ehr080. Epub 2011 Apr 6.
PubMed 21471134Marquez Contreras E, Casado Martinez JJ, Corchado Albalat Y, Chaves Gonzalez R, Grandio A, Losada Velasco C, Obando J, de Eugenio JM, Barrera JM. [Efficacy of an intervention to improve treatment compliance in hyperlipidemias]. Aten Primaria. 2004 May 15;33(8):443-50. doi: 10.1016/s0212-6567(04)79430-5. Spanish.
PubMed 15151791McDonald HP, Garg AX, Haynes RB. Interventions to enhance patient adherence to medication prescriptions: scientific review. JAMA. 2002 Dec 11;288(22):2868-79. doi: 10.1001/jama.288.22.2868.
PubMed 12472329Haynes RB, McKibbon KA, Kanani R, Brouwers C, Oliver T: Interventions to assist patients to follow prescriptions for medications. In: Cochrane Collaboration: Cochrane Library. Oxford: Update Software, 1998.
Parraga-Martinez I, Rabanales-Sotos J, Lago-Deibe F, Tellez-Lapeira JM, Escobar-Rabadan F, Villena-Ferrer A, Blasco-Valle M, Ferreras-Amez JM, Morena-Rayo S, del Campo-del Campo JM, Ayuso-Raya MC, Perez-Pascual JJ. Effectiveness of a combined strategy to improve therapeutic compliance and degree of control among patients with hypercholesterolaemia: a randomised clinical trial. BMC Cardiovasc Disord. 2015 Jan 19;15:8. doi: 10.1186/1471-2261-15-8.
PubMed 25599690
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Combined Strategy to Improve Therapeutic Compliance and Degree of Control Among Patients With Hypercholesterolaemia: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT02314663
- Acronym / sponsor ID
- EFESCOM / GAPALBACETE
- Keywords
- hypercholesterolaemia, medication adherence, primary health care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Gerencia de Atención Primaria, AlbaceteUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: "COMBINED STRATEGY""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 |
| Control group | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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). | Device | Intervention group |
Primary outcome
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
12 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
- Background: PubMed 21712404European Association for Cardiovascular Prevention & Rehabilitation; Reiner Z, Catapano AL, De Backer G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Filardi PP, Riccardi G, Storey RF, Wood D; ESC Committee for Practice Guidelines (CPG) 2008-2010 and 2010-2012 Committees. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011 Jul;32(14):1769-818. doi: 10.1093/eurheartj/ehr158. Epub 2011 Jun 28.
- Background: PubMed 19286092Kotseva K, Wood D, De Backer G, De Bacquer D, Pyorala K, Keil U; EUROASPIRE Study Group. Cardiovascular prevention guidelines in daily practice: a comparison of EUROASPIRE I, II, and III surveys in eight European countries. Lancet. 2009 Mar 14;373(9667):929-40. doi: 10.1016/S0140-6736(09)60330-5.
- Background: PubMed 16987452Vegazo O, Banegas JR, Civeira F, Serrano Aisa PL, Jimenez FJ, Luengo E; Estudio HISPALIPID. [Prevalence of dyslipidemia in outpatients of the Spanish health service: the HISPALIPID Study]. Med Clin (Barc). 2006 Sep 9;127(9):331-4. doi: 10.1157/13092314. Spanish.
- Background: PubMed 12622955Marrugat J, Solanas P, D'Agostino R, Sullivan L, Ordovas J, Cordon F, Ramos R, Sala J, Masia R, Rohlfs I, Elosua R, Kannel WB. [Coronary risk estimation in Spain using a calibrated Framingham function]. Rev Esp Cardiol. 2003 Mar;56(3):253-61. doi: 10.1016/s0300-8932(03)76861-4. Spanish.
- Background: PubMed 22555213Perk J, De Backer G, Gohlke H, Graham I, Reiner Z, Verschuren M, Albus C, Benlian P, Boysen G, Cifkova R, Deaton C, Ebrahim S, Fisher M, Germano G, Hobbs R, Hoes A, Karadeniz S, Mezzani A, Prescott E, Ryden L, Scherer M, Syvanne M, Scholte op Reimer WJ, Vrints C, Wood D, Zamorano JL, Zannad F; European Association for Cardiovascular Prevention & Rehabilitation (EACPR); ESC Committee for Practice Guidelines (CPG). European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Eur Heart J. 2012 Jul;33(13):1635-701. doi: 10.1093/eurheartj/ehs092. Epub 2012 May 3. No abstract available.
- Background: PubMed 19287307Kotseva K, Wood D, De Backer G, De Bacquer D, Pyorala K, Keil U; EUROASPIRE Study Group. EUROASPIRE III: a survey on the lifestyle, risk factors and use of cardioprotective drug therapies in coronary patients from 22 European countries. Eur J Cardiovasc Prev Rehabil. 2009 Apr;16(2):121-37. doi: 10.1097/HJR.0b013e3283294b1d.
- Background: PubMed 19546386Waters DD, Brotons C, Chiang CW, Ferrieres J, Foody J, Jukema JW, Santos RD, Verdejo J, Messig M, McPherson R, Seung KB, Tarasenko L; Lipid Treatment Assessment Project 2 Investigators. Lipid treatment assessment project 2: a multinational survey to evaluate the proportion of patients achieving low-density lipoprotein cholesterol goals. Circulation. 2009 Jul 7;120(1):28-34. doi: 10.1161/CIRCULATIONAHA.108.838466. Epub 2009 Jun 22.
- Background: PubMed 21840055Bermingham M, Hayden J, Dawkins I, Miwa S, Gibson D, McDonald K, Ledwidge M. Prospective analysis of LDL-C goal achievement and self-reported medication adherence among statin users in primary care. Clin Ther. 2011 Sep;33(9):1180-9. doi: 10.1016/j.clinthera.2011.07.007. Epub 2011 Aug 12.
- Background: PubMed 14667488De Geest S, Sabate E. Adherence to long-term therapies: evidence for action. Eur J Cardiovasc Nurs. 2003 Dec;2(4):323. doi: 10.1016/S1474-5151(03)00091-4. No abstract available.
- Background: PubMed 21471134Banegas JR, Lopez-Garcia E, Dallongeville J, Guallar E, Halcox JP, Borghi C, Masso-Gonzalez EL, Jimenez FJ, Perk J, Steg PG, De Backer G, Rodriguez-Artalejo F. Achievement of treatment goals for primary prevention of cardiovascular disease in clinical practice across Europe: the EURIKA study. Eur Heart J. 2011 Sep;32(17):2143-52. doi: 10.1093/eurheartj/ehr080. Epub 2011 Apr 6.
- Background: PubMed 15151791Marquez Contreras E, Casado Martinez JJ, Corchado Albalat Y, Chaves Gonzalez R, Grandio A, Losada Velasco C, Obando J, de Eugenio JM, Barrera JM. [Efficacy of an intervention to improve treatment compliance in hyperlipidemias]. Aten Primaria. 2004 May 15;33(8):443-50. doi: 10.1016/s0212-6567(04)79430-5. Spanish.
- Background: PubMed 12472329McDonald HP, Garg AX, Haynes RB. Interventions to enhance patient adherence to medication prescriptions: scientific review. JAMA. 2002 Dec 11;288(22):2868-79. doi: 10.1001/jama.288.22.2868.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignacio Párraga-Martínez, PhD principal investigator
Health Care Service of Castilla-La Mancha
Questions about this trial
What is this clinical trial studying?
A study testing "COMBINED STRATEGY" in people with Hypercholesterolemia and Medication Adherence, run by Gerencia de Atención Primaria, Albacete.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02314663, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2014.