Clinical trial NCT00552903: Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
Official title: Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Heart Failure
Coronary Disease
Lead sponsor: Paijat-Hame Hospital District
Sponsor class: OTHER
Collaborators: name: Sitra, the Finnish Innovation Fund
name: Pfizer
name: Tampere University
First posted: 2007-11-02
Enrollment: 1500
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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)
timeFrame: 12 months from start of intervention
measure: For patients with diabetes: blood HbA1c at target level (7% or less)
timeFrame: 12 months from start of intervention
Secondary outcomes:
measure: 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
timeFrame: 12 months from start of intervention
Other outcomes:
Locations:
city: Lahti
country: Finland
facility: Päijät-Hämeen Sosiaali - ja Terveysyhtymä
Study officials:
affiliation: Päijät Häme Central Hospital
name: Martti Talja, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sitra, the Finnish Innovation Fund
name: Ilmo Parvinen, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Mustonen 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.
citation: Oksman 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.
citation: Patja 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.