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Completed

NCT Number: NCT02768480

Effectiveness of Phone Calls Intervention on Diabetic Patients After Ambulatory Discharge of a Tertiary Care Center

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).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary care

Other

Patients will be followed by primary care team according to the usual health system routine.

Phone Calls Support and Primary Care

Other

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.

Primary outcomes

  1. Glycemic Control

    Time frame: 1 year

    Evaluation after 1 year of discharge with HbA1c

Secondary outcomes

  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 outcomes

  1. Blood Pressure

    Time frame: 1 year

    Evaluation after 1 year of discharge with blood pressure measurement

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 11, 2016
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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