Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
TerVa
1 other identifier
interventional
1,500
1 country
1
Brief Summary
A randomised trial with individual patients as units of observation will be carried out. Health coaching is used to modify health behaviour and thus improve disease control and health status, as well as use of health care services. A personal health coach is assigned to each patient and they are in weekly contact through telephone. The intervention lasts for 12 months. No intervention is offered to the patients in the control arm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Nov 2007
Typical duration for phase_3 diabetes-mellitus-type-2
1 active site
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
First Submitted
Initial submission to the registry
November 1, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedFirst Posted
Study publicly available on registry
November 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFebruary 4, 2009
February 1, 2009
2 years
November 1, 2007
February 3, 2009
Conditions
Outcome Measures
Primary Outcomes (2)
Blood pressure at target level (140/85 or lower), total cholesterol at target level (4.5 mmol/l or lower), LDL cholesterol at target level (2.5 mmol/l or below), waist circumference at target level (<=94 men, <=80 cm women)
12 months from start of intervention
For patients with diabetes: blood HbA1c at target level (7% or less)
12 months from start of intervention
Secondary Outcomes (1)
Improvement in body mass index, health-related quality of life (15D instrument), amount of exercise, diet, smoking cessation; for patients with heart failure also use of emergency services and NYHA class
12 months from start of intervention
Study Arms (2)
1
EXPERIMENTALActive intervention - personal health coaching provided
2
NO INTERVENTIONControl arm - no intervention, data on health outcomes collected at baseline (entry to the study) and during the 12 month follow-up
Interventions
Personal health coach providing advice and counselling by telephone, weekly contacts
Eligibility Criteria
You may qualify if:
- Diagnosis of type 2 diabetes (medication and HbA1c\>7% and no cardiovascular disease), coronary artery disease (history of myocardial infarction or revascularisation) or heart failure (NYHA II-III and admitted in a hospital for the condition within 2 years)
- Aged 45 years or older
- Resident in the Päijät-Häme health care district
You may not qualify if:
- Classified as ineligible by primary care physician
- Unable to co-operate or participate in health coaching
- Major elective surgery planned within 6 months
- History of major surgery within past 2 years
- Life expectancy \<1 year
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Paijat-Hame Hospital Districtlead
- Sitra, the Finnish Innovation Fundcollaborator
- Pfizercollaborator
- Tampere Universitycollaborator
Study Sites (1)
Päijät-Hämeen Sosiaali - ja Terveysyhtymä
Lahti, 15850, Finland
Related Publications (4)
Mustonen E, Horhammer I, Patja K, Absetz P, Lammintakanen J, Talja M, Kuronen R, Linna M. Eight-year post-trial follow-up of morbidity and mortality of telephone health coaching. BMC Health Serv Res. 2021 Nov 15;21(1):1237. doi: 10.1186/s12913-021-07263-w.
PMID: 34781936DERIVEDMustonen E, Horhammer I, Absetz P, Patja K, Lammintakanen J, Talja M, Kuronen R, Linna M. Eight-year post-trial follow-up of health care and long-term care costs of tele-based health coaching. Health Serv Res. 2020 Apr;55(2):211-217. doi: 10.1111/1475-6773.13251. Epub 2019 Dec 29.
PMID: 31884682DERIVEDOksman E, Linna M, Horhammer I, Lammintakanen J, Talja M. Cost-effectiveness analysis for a tele-based health coaching program for chronic disease in primary care. BMC Health Serv Res. 2017 Feb 15;17(1):138. doi: 10.1186/s12913-017-2088-4.
PMID: 28202032DERIVEDPatja K, Absetz P, Auvinen A, Tokola K, Kyto J, Oksman E, Kuronen R, Ovaska T, Harno K, Nenonen M, Wiklund T, Kettunen R, Talja M. Health coaching by telephony to support self-care in chronic diseases: clinical outcomes from The TERVA randomized controlled trial. BMC Health Serv Res. 2012 Jun 10;12:147. doi: 10.1186/1472-6963-12-147.
PMID: 22682298DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martti Talja, MD
Päijät Häme Central Hospital
- STUDY CHAIR
Ilmo Parvinen, MD
Sitra, the Finnish Innovation Fund
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 1, 2007
First Posted
November 2, 2007
Study Start
November 1, 2007
Primary Completion
November 1, 2009
Study Completion
May 1, 2010
Last Updated
February 4, 2009
Record last verified: 2009-02