Teleconsultation in Counter-reference Between Tertiary and Primary Care for Patients With Benign Prostatic Hyperplasia
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|ClinicalTrials.gov Identifier: NCT02947958|
Recruitment Status : Recruiting
First Posted : October 28, 2016
Last Update Posted : October 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Hyperplasia||Other: Teleconsultation Other: Hospital (control)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||284 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Effectiveness of the Use of Teleconsultation in Qualifying Counter-reference Between Tertiary and Primary Care for Patients With Benign Prostatic Hyperplasia: Randomized Clinical Trial of Noninferiority|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||April 2017|
Tele consultation (experimental) - after the randomization the patient is guided to seek primary care under teleconsultation supervision to keep his treatment. One year later the patient's symptoms are reassessed in a medical consultation.
Teleconsultation - the teleconsultation usage in chronic diseases, such as benign hyperplasia, seems to be a promising scenario. Once the patient symptoms are evaluated and diagnosed as a stable disease he is able to keep his treatment annually. In a way to do not overload de tertiary system, such monitoring could be done under a teleconsultation with a urological supervision in the primary care.
Active Comparator: Hospital
Hospital (control) - after the randomization the patient is guided to keep his treatment in the tertiary care as usual. One year later the patient's symptoms are reassessed in a medical consultation.
Other: Hospital (control)
The patient will keep his usual care at the tertiary care.
- Change from baseline Low Urinary Tract Symptoms (LUTS) [ Time Frame: 12 months ]Low urinary tract symptoms are assessed through International Prostate Score System (IPSS) which includes seven main important symptoms of benign prostate hyperplasia, validated to portuguese. Each symptom is graduated from zero to five. This score classifies the symptoms of the lower urinary tract that will be assessed at randomization and after twelve months in each arm of the study.
- Occurrence of Acute Urinary Retention (AUR) [ Time Frame: 12 months ]The occurrence of spontaneous obstruction of the urinary flow secondary to the benign prostatic hyperplasia.
- Change from baseline Serum Creatinine [ Time Frame: 12 months ]Serum creatinine values will be assessed at randomization and after twelve months
- Change from baseline Serum Urea [ Time Frame: 12 months ]Serum urea values will be assessed at randomization and after twelve months
- Change from baseline Prostatic Specific Antigen (PSA) [ Time Frame: 12 months ]Prostatic specific antigen serum values will be assessed at randomization and after twelve months.
- Occurrence of Urinary infection [ Time Frame: 12 months ]Occurrence of urinary tract infection during the study will be assessed through urine cultures
- Adhesion to Medications [ Time Frame: 12 months ]The adhesion to prescribed medications will be assessed after 12 months of the randomization
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947958
|Contact: Brasil S. Neto, MdPgfirstname.lastname@example.org|
|Hospital De Clinicas De Porto Alegre||Recruiting|
|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|
|Contact: Brasil S Neto, MdPg 555133598286 email@example.com|
|Principal Investigator:||Brasil S Neto, MdPg||Hospital de Clinicas de Porto Alegre|