Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, type 2, heart failure, coronary disease
Treatment health coaching
Phase phase 3
Sponsor Paijat-Hame Hospital District
Collaborator Sitra, the Finnish Innovation Fund
Start date November 2007
End date November 2009
Trial size 1500 participants
Trial identifier NCT00552903, PHKS-Z80

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Active intervention - personal health coaching provided
health coaching Counseling, health education
Personal health coach providing advice and counselling by telephone, weekly contacts
(No Intervention)
Control arm - no intervention, data on health outcomes collected at baseline (entry to the study) and during the 12 month follow-up

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)
time frame: 12 months from start of intervention
For patients with diabetes: blood HbA1c at target level (7% or less)
time frame: 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
time frame: 12 months from start of intervention

Eligibility Criteria

Male or female participants at least 45 years old.

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

Additional Information

Official title Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
Principal investigator Martti Talja, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by Paijat-Hame Hospital District.