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

NCT ID: NCT02768480

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-12-31

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).

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Primary Care

Patients will be followed by primary care team exclusively.

Group Type: ACTIVE_COMPARATOR

Primary Care

Intervention Type: OTHER

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

Phone Calls Support and Primary Care

Patients will be followed by primary care team and supported by periodic nurse phone calls.

Group Type: EXPERIMENTAL

Phone Calls Support and Primary Care

Intervention Type: 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.

Interventions

Primary Care

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra P Silveiro, MD

Role: STUDY_DIRECTOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

Moreira AM, Rados DV, de Farias CB, Coelli S, de Almeida Faller L, Dos Santos LF, Matzenbacher AM, Katz N, Harzeim E, Silveiro SP. Effects of nurse tele support via telephone calls on transition between specialized and primary care in type 2 diabetes mellitus patients: a CONSORT-compliant randomized clinical trial. Endocrine. 2025 Mar;87(3):978-986. doi: 10.1007/s12020-024-04095-6. Epub 2024 Nov 29.

Reference Type: DERIVED

PMID: 39614069 (View on PubMed)

Moreira AM, Marobin R, Rados DV, de Farias CB, Coelli S, Bernardi BL, Faller LA, Dos Santos LF, Matzenbacher AM, Katz N, Harzheim E, Silveiro SP; TelessaudeRS. Effects of nurse telesupport on transition between specialized and primary care in diabetic patients: study protocol for a randomized controlled trial. Trials. 2017 May 18;18(1):222. doi: 10.1186/s13063-017-1954-z.

Reference Type: DERIVED

PMID: 28521796 (View on PubMed)

Other Identifiers

150503

Identifier Type: -

Identifier Source: org_study_id