Telecoaching of People With Type 2 Diabetes in Primary Care

Type 2 Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612520
• Other study ID #: S53665
• Status: Completed
• Phase: N/A
• First received: June 4, 2012
• Last updated: February 2, 2015
• Start date: April 2012
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to analyze the effectiveness and the cost-effectiveness of telecoching in improving glyceamic control and other modifiable risk factors in patients with type 2 diabetes compared to usual care only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 574
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients with type 2 diabetes between 18 and 75 years old on the day of the selection

Exclusion Criteria:

• Debilitating coexisting medical condition (e.g. dialysis, mental illness, cancer)

• Residents of long term care facilities

• Pregnancy

• Incapable of telephone communication in Dutch

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Telenursing
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• telecoaching
The COACH program trains patients to 'drive' the process of achieving and maintaining the target levels for their risk factors while working in association with their GP. The telephone coaching is aimed at improving self-efficacy by adhering to the prescribed therapy and making relevant behavior changes. The coaching model is a continuous five-stage coaching cycle: Stage 1. Finding out what the patient knows; Stage 2. Telling the patient what they should know; Stage 3. Assertiveness training; Stage 4. Setting an action plan; Stage 5. Reassessment at the next coaching session (monitoring). The coach monitors and registers: the biomedical risk factors, the lifestyle/behavioral risk factors and use of the recommended medications. Coaching is focused on eliminating the knowledge gap and motivating the patient to apply the appropriate lifestyle and medical therapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the absolute change in HbA1c		baseline; 6 months and 18 months	No