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Trial record 1 of 1 for:    NCT02768480
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Effectiveness of Phone Calls Intervention on Diabetic Patients After Ambulatory Discharge of a Tertiary Care Center

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2016 by Hospital de Clinicas de Porto Alegre
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT02768480
First received: April 29, 2016
Last updated: May 9, 2016
Last verified: May 2016
  Purpose
The study is a randomized clinical trial, controlled, open label that aimed to compare two groups after discharge of a tertiary care: type 2 diabetes patients followed exclusively by primary care (control group) and patients followed by primary care and supported by phone calls (intervention group).

Condition Intervention Phase
Diabetes Mellitus Other: Primary Care Other: Phone Calls Support and Primary Care Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official 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

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Glycemic Control [ Time Frame: 1 year ]
    Evaluation after 1 year of discharge with HbA1c


Secondary Outcome Measures:
  • Visits to the doctor, nurse, nutritionist, psychologist [ Time Frame: 1 year ]
    Evaluation after 1 year of discharge with a structured questionnaire

  • Rate of referring to tertiary care [ Time Frame: 1 year ]
    Evaluation after 1 year of discharge with a structured questionnaire

  • Care satisfaction with diabetes treatment [ Time Frame: 1 year ]
    Evaluation after 1 year of discharge with a structured questionnaire

  • Emergency visits because of diabetes acute complications [ Time Frame: 1 year ]
    Evaluation after 1 year of discharge with a structured questionnaire

  • Hypoglycaemic rate [ Time Frame: 1 year ]
    Evaluation after 1 year of discharge with a structured questionnaire

  • Treatment adherence [ Time Frame: 1 year ]
    Evaluation after 1 year of discharge with the Brief Medication Questionnaire

  • Lipid control [ Time Frame: 1 year ]
    Evaluation after 1 year of discharge with blood lipid levels

  • Antiplatelet therapy/ statin use [ Time Frame: 1 year ]
    Evaluation after 1 year of discharge with a structured questionnaire

  • Nephropathy emergence or worsening [ Time Frame: 1 year ]
    Evaluation after 1 year of discharge with microalbuminuria and blood creatinine measurement

  • Retinopathy emergence or worsening [ Time Frame: 1 year ]
    Evaluation after 1 year of discharge with retinography and ophthalmologist advice if is necessary.

  • Major cardiovascular events [ Time Frame: 1 year ]
    Evaluation after 1 year of discharge with a structured questionnaire

  • Death [ Time Frame: 1 year ]
    Evaluation after 1 year of discharge with telephone contact and active search


Other Outcome Measures:
  • Blood Pressure [ Time Frame: 1 year ]
    Evaluation after 1 year of discharge with blood pressure measurement


Estimated Enrollment: 128
Study Start Date: June 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Primary Care
Patients will be followed by primary care team exclusively.
Other: Primary Care
Patients will be followed by primary care team according to the usual health system routine.
Experimental: Phone Calls Support and Primary Care
Patients will be followed by primary care team and supported by periodic nurse phone calls.
Other: Phone Calls Support and Primary Care
Patients in intervention group will receive periodic phone calls (every three months) and will have a toll-free number to resolve questions about the disease management. The phone-calls will be performed by trained nurses and will follow a structured format. Nurses will address some topics: patient's treatment adherence, technique of insulin administration, disease understanding, hypoglycaemia management, healthy diet, smoke cessation and foot care.

Detailed Description:
The investigators designed a randomized controlled trial. Patients with stable and controlled type 2 diabetes, and considered to be eligible to discharge from specialized care to primary care will be included. Patients with severe neuropathy, not controlled ischemic heart disease and nephropathy stage IV/V will be excluded. Enrolled patients will be randomized in two groups: follow-up supported by periodic nurse phone calls plus primary care (intervention group) or followed by primary care team (control group). The intervention group will receive regular telephone calls (every 3 months for 1 year) and will have a toll-free number to resolve questions about the disease management. Main outcome is the glycemic control between groups after 1 year of follow-up. Secondary outcomes include: rate of hypoglycaemia, blood pressure control,emergency visits, nephropathy progression and death.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02768480

Contacts
Contact: Sandra P Silveiro, MD, PhD 55 51 33598127 silveirosandra@gmail.com
Contact: Ana Marina S Moreira, MD 55 51 33598127 anamarinamoreira@gmail.com

Locations
Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Contact: Ana Marina S Moreira, MD    55 51 33598127    anamarinamoreira@gmail.com   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Study Director: Sandra P Silveiro, MD Hospital de Clínicas de Porto Alegre
  More Information

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02768480     History of Changes
Other Study ID Numbers: 150503
Study First Received: April 29, 2016
Last Updated: May 9, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Hospital de Clinicas de Porto Alegre:
Diabetes
phone calls
glycemic control

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 23, 2017