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Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease

Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00552903
Acronym
TerVa
Enrollment
1500
Registered
2007-11-02
Start date
2007-11-30
Completion date
2010-05-31
Last updated
2009-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease, Diabetes Mellitus, Type 2, Heart Failure

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.

Interventions

BEHAVIORALHealth coaching

Personal health coach providing advice and counselling by telephone, weekly contacts

Sponsors

Sitra, the Finnish Innovation Fund
CollaboratorOTHER
Pfizer
CollaboratorINDUSTRY
Tampere University
CollaboratorOTHER
Paijat-Hame Hospital District
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 class12 months from start of intervention

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026