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

Study Overview
=================
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.

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

Conditions
-----------------
Diabetes Mellitus, Type 2, Heart Failure, Coronary Disease

Intervention / Treatment
-----------------
* Behavioral: Health coaching


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Active intervention - personal health coaching provided | Behavioral: Health coaching<br>* Personal health coach providing advice and counselling by telephone, weekly contacts<br>* Other names: Counseling, health education;|
| No Intervention: 2<br>Control arm - no intervention, data on health outcomes collected at baseline (entry to the study) and during the 12 month follow-up | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time 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 class |  | 12 months from start of intervention |