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
Recruitment status was Active, not recruiting
Sponsor:
University of Sao Paulo
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
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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:
Drug Information available for:
Hydrochlorothiazide
Calcium Gluconate
Atenolol
Amlodipine
Amlodipine besylate
Losartan
Losartan potassium
U.S. FDA Resources
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 May 23, 2013