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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02768480
Date of registration:	29/04/2016
Prospective Registration:	No
Primary sponsor:	Hospital de Clinicas de Porto Alegre
Public title:	Effectiveness of Phone Calls Intervention on Diabetic Patients After Ambulatory Discharge of a Tertiary Care Center
Scientific title:	Evaluation of the Effectiveness of Phone Calls Intervention (TelessaúdeRS) on Diabetic Patients After Ambulatory Discharge of a Tertiary Care Center: A Randomized Clinical Trial
Date of first enrolment:	June 2015
Target sample size:	147
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02768480
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Brazil

Contacts

Name:	Sandra P Silveiro, MD
Address:
Telephone:
Email:
Affiliation:	Hospital de Clínicas de Porto Alegre

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with type 2 diabetes;

- Patients who met discharges criteria according to endocrinology team;

- Patients with HbA1C < 8%.

Exclusion Criteria:

- Patients with stage IV or V nephropathy;

- Patients with not controlled Ischemic heart disease;

- Patients with severe autonomous or peripheral neuropathy.

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Intervention(s)

Other: Primary Care

Other: Phone Calls Support and Primary Care

Primary Outcome(s)

Glycemic Control [Time Frame: 1 year]

Secondary Outcome(s)

Treatment adherence [Time Frame: 1 year]

Visits to the doctor, nurse, nutritionist, psychologist [Time Frame: 1 year]

Rate of referring to tertiary care [Time Frame: 1 year]

Retinopathy emergence or worsening [Time Frame: 1 year]

Antiplatelet therapy/ statin use [Time Frame: 1 year]

Major cardiovascular events [Time Frame: 1 year]

Care satisfaction with diabetes treatment [Time Frame: 1 year]

Emergency visits because of diabetes acute complications [Time Frame: 1 year]

Death [Time Frame: 1 year]

Hypoglycaemic rate [Time Frame: 1 year]

Lipid control [Time Frame: 1 year]

Nephropathy emergence or worsening [Time Frame: 1 year]

Secondary ID(s)

150503

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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