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

Paijat-Hame Hospital District

Status and phase: Unknown; Phase 3

Conditions: Heart Failure; Diabetes Mellitus, Type 2; Coronary Disease

Treatments: Behavioral: Health coaching

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00552903

PHKS-Z80

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

1

Experimental group

Description:

Active intervention - personal health coaching provided

Treatment:

Behavioral: Health coaching

2

No Intervention group

Description:

Control arm - no intervention, data on health outcomes collected at baseline (entry to the study) and during the 12 month follow-up