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

NCT00813722 | Unknown Phase 4

• 1 other identifier: PROMEPA
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Blood Pressure

Keywords

adherence; blood pressure; hypertension; compliance; atenolol; hydrochlorothiazide; amlodipine; losartan

Outcome Measures

Primary Outcomes (1)

• Blood pressure control

  1 year

Study Arms (4)

phone calls

ACTIVE COMPARATOR

patients received phone calls

Behavioral: phone call

no phone calls

PLACEBO COMPARATOR

patients received no phone calls

Behavioral: phone call

current treatment

ACTIVE COMPARATOR

calcium chanel blocker and at1 antagonist

Drug: amlodipine (calcium chanel blocker) and losartan (at1 antagonist)

tradittional treatment

ACTIVE COMPARATOR

beta blocker and diuretic

Drug: atenolol (beta blocker) and hydrochlorothiazide (diuretic)

Interventions

phone call BEHAVIORAL

patients received or not phone calls to give orientation abou treatment

Also known as: phone calls

no phone calls; phone calls

amlodipine (calcium chanel blocker) and losartan (at1 antagonist) DRUG

2,5 mg tid and 25 mg tid

current treatment

atenolol (beta blocker) and hydrochlorothiazide (diuretic) DRUG

25 mg tid and 12,5 mg tid

tradittional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (2)

Sao Paulo University

São Paulo, São Paulo, 05403-900, Brazil

Location

University of Sao Paulo

São Paulo, São Paulo, 05405-000, Brazil

Location

MeSH Terms

Conditions

Hypertension; Patient Compliance

Interventions

Amlodipine; Losartan; Atenolol; Adrenergic beta-Antagonists; Hydrochlorothiazide; Diuretics

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Tetrazoles; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Natriuretic Agents

Study Officials

• Decio Mion Jr, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 23, 2008
• Study Start: March 1, 1999
• Primary Completion: January 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 23, 2008

Record last verified: 2008-12

Locations

BR (2)