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

Phase 3

• Conditions: Diabetes Mellitus, Type 2; Heart Failure; Coronary Disease
• Interventions: Behavioral: Health coaching

• Registration Number: NCT00552903
• Lead Sponsor: Paijat-Hame Hospital District

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-01
• Study First Submitted QC: 2007-11-01
• Study First Posted: 2007-11-02
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-03
• Last Update Posted: 2009-02-04
• Primary Completion: 2009-11
• Study Completion: 2010-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Health coaching	Active intervention - personal health coaching provided

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Päijät-Hämeen Sosiaali - ja Terveysyhtymä; 🇫🇮 Lahti, Finland