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

NCT ID: NCT00552903

Last Updated: 2009-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-05-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2 Heart Failure Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Active intervention - personal health coaching provided

Group Type EXPERIMENTAL

Health coaching

Intervention Type BEHAVIORAL

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

2

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Health coaching

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Counseling, health education

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sitra, the Finnish Innovation Fund

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Tampere University

OTHER

Sponsor Role collaborator

Paijat-Hame Hospital District

OTHER

Sponsor Role lead

Responsible Party

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Päijät-Häme Health and Welfare Trust

Principal Investigators

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Martti Talja, MD

Role: PRINCIPAL_INVESTIGATOR

Päijät Häme Central Hospital

Ilmo Parvinen, MD

Role: STUDY_CHAIR

Sitra, the Finnish Innovation Fund

Locations

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Päijät-Hämeen Sosiaali - ja Terveysyhtymä

Lahti, , Finland

Site Status

Countries

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Finland

References

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Mustonen E, Horhammer I, Patja K, Absetz P, Lammintakanen J, Talja M, Kuronen R, Linna M. Eight-year post-trial follow-up of morbidity and mortality of telephone health coaching. BMC Health Serv Res. 2021 Nov 15;21(1):1237. doi: 10.1186/s12913-021-07263-w.

Reference Type DERIVED
PMID: 34781936 (View on PubMed)

Mustonen E, Horhammer I, Absetz P, Patja K, Lammintakanen J, Talja M, Kuronen R, Linna M. Eight-year post-trial follow-up of health care and long-term care costs of tele-based health coaching. Health Serv Res. 2020 Apr;55(2):211-217. doi: 10.1111/1475-6773.13251. Epub 2019 Dec 29.

Reference Type DERIVED
PMID: 31884682 (View on PubMed)

Oksman E, Linna M, Horhammer I, Lammintakanen J, Talja M. Cost-effectiveness analysis for a tele-based health coaching program for chronic disease in primary care. BMC Health Serv Res. 2017 Feb 15;17(1):138. doi: 10.1186/s12913-017-2088-4.

Reference Type DERIVED
PMID: 28202032 (View on PubMed)

Patja K, Absetz P, Auvinen A, Tokola K, Kyto J, Oksman E, Kuronen R, Ovaska T, Harno K, Nenonen M, Wiklund T, Kettunen R, Talja M. Health coaching by telephony to support self-care in chronic diseases: clinical outcomes from The TERVA randomized controlled trial. BMC Health Serv Res. 2012 Jun 10;12:147. doi: 10.1186/1472-6963-12-147.

Reference Type DERIVED
PMID: 22682298 (View on PubMed)

Other Identifiers

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PHKS-Z80

Identifier Type: -

Identifier Source: org_study_id

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