ClinicalTrials.gov
ClinicalTrials.gov Menu

Telecoaching of People With Type 2 Diabetes in Primary Care

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.
ClinicalTrials.gov Identifier: NCT01612520
Recruitment Status : Completed
First Posted : June 6, 2012
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):
Irina Odnoletkova, Katholieke Universiteit Leuven

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Telenursing Behavioral: telecoaching Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 574 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : April 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 Posted: June 6, 2012    Key Record Dates
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