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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

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ClinicalTrials.gov Identifier: NCT02768480
Recruitment Status : Active, not recruiting
First Posted : May 11, 2016
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Diabetes Mellitus Other: Primary Care Other: Phone Calls Support and Primary 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018
Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

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


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

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

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

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

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

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

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

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

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

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

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

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


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


Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02768480


Locations
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
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
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
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