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

Heart Failure Clinical Trial

— TerVa  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00552903
• Other study ID #: PHKS-Z80
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 2007
• Last updated: February 3, 2009
• Start date: November 2007
• Est. completion date: May 2010

Study information

• Verified date: February 2009
• Source: Paijat-Hame Hospital District
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: ETENE/TUKIJAFinland: Medicolegal BoardFinland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: May 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus, Type 2
• Heart Diseases
• Heart Failure

Intervention

Behavioral:
• Health coaching
Personal health coach providing advice and counselling by telephone, weekly contacts

Locations

Country	Name	City	State
Finland	Päijät-Hämeen Sosiaali - ja Terveysyhtymä	Lahti

Sponsors (4)

Lead Sponsor	Collaborator
Paijat-Hame Hospital District	Pfizer, Sitra, the Finnish Innovation Fund, University of Tampere

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	For patients with diabetes: blood HbA1c at target level (7% or less)		12 months from start of intervention	No
Secondary	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	No