Effect of Active Telephone Calls in the Compliance of Hypertensive Patients With Treatment

• Status: Unknown status
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the importance of providing guidelines to patients via active telephone calls in blood pressure control and in the discontinuation of treatment among hypertensive patients. Hypertensives (N = 354) who could receive telephone calls to be reminded of the dates of their medical appointments and to be instructed about hypertension were distributed into two groups: a) "uncomplicated" - hypertensives with no other concurrent diseases; and b) "complicated" - severe hypertensives (mean diastolic ≥ 110 mm Hg with or without medication) or comorbidities. All patients, except those excluded (n=44), were open block randomized to follow two treatment regimens: "traditional" or "current" and to receive active telephone calls ("phone calls" group) or not to receive telephone calls ("no phone calls" group).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Treatments: Adrenergic beta-Antagonists; Amlodipine; Atenolol; Calcium; Diuretics; Hydrochlorothiazide; Losartan

Criteria

Inclusion Criteria:

• The patients studied were those with essential hypertension who could receive telephone calls to be reminded of the dates of their medical appointments and to receive guidance about hypertension

• Patients were of both genders, from any ethnic background, over 18 years old and with body mass index below 40 kg/m2, and were enrolled in the study after signing a free and informed consent term

Exclusion Criteria:

• Blood pressure < 140/90 mm Hg without antihypertensive medication

• Pregnant women or nursing mothers

• Patients with secondary hypertension

• White-coat hypertension with systolic pressure ≥ 140 mm Hg and/or diastolic pressure ≥ 90 mm Hg at the doctor's office and awake mean systolic pressure < 135 mm Hg or awake mean diastolic pressure < 85 mm Hg without antihypertensive medication

• Malignant hypertension

• Presence of liver dysfunction evidenced by the patient's clinical history or by one of the liver function tests with levels twice the normal values (alkaline phosphatase, total bilirubin, aspartate aminotransferase)

• Patients with clinical conditions that might interfere with the total conformity with the study or those who might have increased risk for participating in the study

• Patients with previous history of hypersensitivity reaction to the study medications

• Patients with a history of alcoholism, drug abuse or mental disorders that might invalidate the free and informed consent or limit the patient's ability to meet the protocol rules

• Patients who had participated in any other studies involving investigational drugs or drugs already marketed within the previous month, before enrollment in this study or concomitantly with this study.