Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2 Heart Failure Coronary Disease	Behavioral: Health coaching	Phase III

MedlinePlus related topics:

Diabetes Heart Diseases Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study

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

Further study details as provided by Paijat-Hame Hospital District:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
For patients with diabetes: blood HbA1c at target level (7% or less) [ Time Frame: 12 months from start of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1500
Study Start Date:	November 2007
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Active intervention - personal health coaching provided	Behavioral: Health coaching Personal health coach providing advice and counselling by telephone, weekly contacts
2: No Intervention Control arm - no intervention, data on health outcomes collected at baseline (entry to the study) and during the 12 month follow-up

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552903

Contacts


Contact: Erja Oksman, MPH	358 3 81911 ext 5912	erja.oksman@phsotey.fi

Contact: Päivi Suikki, RN	358 40 728 4070	paivi.suikki@medineuvo.com

Locations


Finland
	Päijät-Hämeen Sosiaali - ja Terveysyhtymä	Recruiting
	Lahti, Finland, 15850
	Contact: Erja Oksman, MPH 358 3 81911 erja.oksman@phsotey.fi
	Sub-Investigator: Raimo Kettunen, MD
	Principal Investigator: Martti Talja, MD

Sponsors and Collaborators

Paijat-Hame Hospital District

SITRA - Finnish Innovation Fund

Pfizer

University of Tampere

Investigators


Principal Investigator:	Martti Talja, MD	Päijät-Häme Central Hospital

Study Chair:	Ilmo Parvinen, MD	SITRA - Finnish Innovation Fund

More Information

Responsible Party:	Päijät-Häme Health and Welfare Trust ( Dr Martti Talja )
Study ID Numbers:	PHKS-Z80
First Received:	November 1, 2007
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00552903
Health Authority:	Finland: ETENE/TUKIJA; Finland: Medicolegal Board; Finland: Ministry of Health

Study placed in the following topic categories:

Heart Failure

Heart Diseases

Metabolic Diseases

Myocardial Ischemia

Diabetes Mellitus

Vascular Diseases

Endocrine System Diseases

Ischemia

Coronary Disease

Diabetes Mellitus, Type 2

Neoplasm Metastasis

Endocrinopathy

Glucose Metabolism Disorders

Metabolic disorder

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 07, 2008

Sponsors and Collaborators:	Paijat-Hame Hospital District SITRA - Finnish Innovation Fund Pfizer University of Tampere
Information provided by:	Paijat-Hame Hospital District
ClinicalTrials.gov Identifier:	NCT00552903