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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01612520
Other study ID # S53665
Secondary ID
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


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
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