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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University of Sao Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00813722
First received: December 17, 2008
Last updated: December 19, 2008
Last verified: December 2008
  Purpose

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).


Condition Intervention Phase
Blood Pressure
Behavioral: phone call
Drug: amlodipine (calcium chanel blocker) and losartan (at1 antagonist)
Drug: atenolol (beta blocker) and hydrochlorothiazide (diuretic)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Active Telephone Calls in the Compliance of Hypertensive Patients With Treatment: An Open and Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Blood pressure control [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 400
Study Start Date: March 1999
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: phone calls
patients received phone calls
Behavioral: phone call
patients received or not phone calls to give orientation abou treatment
Other Name: phone calls
Placebo Comparator: no phone calls
patients received no phone calls
Behavioral: phone call
patients received or not phone calls to give orientation abou treatment
Other Name: phone calls
Active Comparator: current treatment
calcium chanel blocker and at1 antagonist
Drug: amlodipine (calcium chanel blocker) and losartan (at1 antagonist)
2,5 mg tid and 25 mg tid
Active Comparator: tradittional treatment
beta blocker and diuretic
Drug: atenolol (beta blocker) and hydrochlorothiazide (diuretic)
25 mg tid and 12,5 mg tid

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813722

Locations
Brazil
Sao Paulo University
Sao Paulo, Brazil, 05403-900
University of Sao Paulo
Sao Paulo, Brazil, 05405-000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Decio Mion Jr, MD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Décio Mion Jr., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00813722     History of Changes
Other Study ID Numbers: PROMEPA
Study First Received: December 17, 2008
Last Updated: December 19, 2008
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
adherence
blood pressure
hypertension
compliance
atenolol
hydrochlorothiazide
amlodipine
losartan

Additional relevant MeSH terms:
Adrenergic beta-Antagonists
Atenolol
Losartan
Hydrochlorothiazide
Amlodipine
Diuretics
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Calcium Channel Blockers
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on April 17, 2014