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

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

Sponsors

Lead Sponsor: Paijat-Hame Hospital District

Collaborator: Sitra, the Finnish Innovation Fund
Pfizer
Tampere University

Source 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.

Overall Status Unknown status
Start Date November 2007
Completion Date May 2010
Primary Completion Date November 2009
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure 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
Measure 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
Enrollment 1500
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Health coaching

Description: Personal health coach providing advice and counselling by telephone, weekly contacts

Arm Group Label: 1

Other Name: Counseling, health education

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

Gender: All

Minimum Age: 45 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility: Päijät-Hämeen Sosiaali - ja Terveysyhtymä
Location Countries

Finland

Verification Date

February 2009

Responsible Party

Name Title: Dr Martti Talja

Organization: Päijät-Häme Health and Welfare Trust

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Experimental

Description: Active intervention - personal health coaching provided

Label: 2

Type: No Intervention

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

Acronym TerVa
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov