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Telecoaching of People With Type 2 Diabetes in Primary Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01612520
First Posted: June 6, 2012
Last Update Posted: February 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Irina Odnoletkova, Katholieke Universiteit Leuven
  Purpose
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.

Condition Intervention
Type 2 Diabetes Mellitus Telenursing Behavioral: telecoaching

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Irina Odnoletkova, Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • the absolute change in HbA1c [ Time Frame: baseline; 6 months and 18 months ]

Enrollment: 574
Study Start Date: April 2012
Study Completion Date: January 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: telecoaching 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.

No Intervention: control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Irina Odnoletkova, PhD Student in Biomedical sciences, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01612520     History of Changes
Other Study ID Numbers: S53665
First Submitted: June 4, 2012
First Posted: June 6, 2012
Last Update Posted: February 3, 2015
Last Verified: February 2015

Keywords provided by Irina Odnoletkova, Katholieke Universiteit Leuven:
type 2 Diabetes Mellitus
telenursing
RCT
economic analysis

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases