NCT01612520

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
574

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable type-2-diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 3, 2015

Status Verified

February 1, 2015

Enrollment Period

1.8 years

First QC Date

June 4, 2012

Last Update Submit

February 2, 2015

Conditions

Keywords

type 2 Diabetes MellitustelenursingRCTeconomic analysis

Outcome Measures

Primary Outcomes (1)

  • the absolute change in HbA1c

    baseline; 6 months and 18 months

Study Arms (2)

telecoaching

ACTIVE COMPARATOR
Behavioral: telecoaching

control

NO INTERVENTION

Interventions

telecoachingBEHAVIORAL

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.

telecoaching

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Debilitating coexisting medical condition (e.g. dialysis, mental illness, cancer)
  • Residents of long term care facilities
  • Pregnancy
  • Incapable of telephone communication in Dutch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Odnoletkova I, Buysse H, Nobels F, Goderis G, Aertgeerts B, Annemans L, Ramaekers D. Patient and provider acceptance of telecoaching in type 2 diabetes: a mixed-method study embedded in a randomised clinical trial. BMC Med Inform Decis Mak. 2016 Nov 9;16(1):142. doi: 10.1186/s12911-016-0383-3.

  • Odnoletkova I, Ramaekers D, Nobels F, Goderis G, Aertgeerts B, Annemans L. Delivering Diabetes Education through Nurse-Led Telecoaching. Cost-Effectiveness Analysis. PLoS One. 2016 Oct 11;11(10):e0163997. doi: 10.1371/journal.pone.0163997. eCollection 2016.

  • Odnoletkova I, Goderis G, Nobels F, Aertgeerts B, Annemans L, Ramaekers D. Nurse-led telecoaching of people with type 2 diabetes in primary care: rationale, design and baseline data of a randomized controlled trial. BMC Fam Pract. 2014 Feb 4;15:24. doi: 10.1186/1471-2296-15-24.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student in Biomedical sciences

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 6, 2012

Study Start

April 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2015

Last Updated

February 3, 2015

Record last verified: 2015-02