Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effectiveness of a Combined Strategy to Improve Therapeutic Compliance and Degree of Control Among Patients With Hypercholesterolaemia: a Randomised Clinical Trial
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.


Options:
A: Inclusion Criteria:

* Treated or untreated uncontrolled essential arterial hypertension (office systolic blood pressure \>140 or diastolic \>90 mmHg + day-time systolic blood pressure \>135 or day-time diastolic blood pressure \>85 mmHg)
* Metabolic syndrome (ATP III criteria)

Exclusion Criteria:

* Secondary arterial hypertension
* Severe liver or kidney disease
* Immunological disease
* Cardiac arrhythmias
B: Inclusion Criteria:

* Enrolled in one of three Durham Veterans Affairs Medical Center (DVAMC) Primary Care Clinics affiliated with the hospital or the Raleigh Community-Based Outpatient Clinic (CBOC) for at least one year;
* At least one visit to a primary care physician (PCP) at the Raleigh CBOC or Durham Veterans Affairs Medical Center (VAMC) associated primary care clinics in the previous 12 months;
* Outpatient diagnostic code for hypertension and/or hypercholesterolemia and lab values indicating either poorly controlled BP levels (\>150/90 Hg) AND/OR LDL (\>130mg/dl) in the previous year.

Exclusion Criteria:

* diagnosed with metastatic cancer,
* diagnosed with dementia,
* active diagnosis of psychosis,
* treated with dialysis,
* most recent creatinine lab level \>2.5 or no creatinine lab value within past year
* hospitalized for a stroke, heart attack, or had surgery for blocked arteries in the past 3 months,
* participating in another interventional trial,
* not currently receiving care at the Durham VAMC or the Raleigh CBOC
* resident of a nursing home,
* hard time seeing type/printing on books, magazines articles, etc.
* hard time hearing on the telephone
* limited/no access to telephone
* plans to move medical care from DVAMC or Raleigh CBOC in next 12 months
* CVD care is currently being managed by a clinical pharmacist
* HbA1C value in the last 90day \> 10% and patient is currently not on an insulin regimen.
C: 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.
D: Inclusion Criteria:

* Adult (≥18 y/o)
* At least one BP of systolic blood pressure (SBP) ≥160 or a diastolic blood pressure (DBP) ≥100 or only BP performed prior to enrollment is SBP ≥160 or a DBP ≥100 (If the patient has repeated measurements after achieving Criteria 1, but prior to being enrolled, at least one of the repeat BP remains SBP ≥140 or a DBP ≥90)
* Must have mobile phones with text-messaging capability
* Likely to be discharged from the ED

Exclusion Criteria:

* Adult who is in an urgent condition
* Unable to read
* Non-English speaking
* Incarcerated/ institutionalized resident
* Pregnant, or has a pre-existing condition that makes follow-up for 4 months unlikely.

Answer: C