Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
NCT00552903
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus, Heart Failure, Coronary Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
45 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
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Type 2 Diabetes Mellitus, Heart Failure, Coronary DiseaseRandomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
NCT00552903
- Lahti,
ALL GENDERS
45 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease | ||||||
| Official Title ICMJE | Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease | ||||||
| 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. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention | ||||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Health coaching
Personal health coach providing advice and counselling by telephone, weekly contacts Other Name: Counseling, health education | ||||||
| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Unknown status | ||||||
| Estimated Enrollment ICMJE | 1500 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | May 2010 | ||||||
| Estimated Primary Completion Date | November 2009 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 45 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Finland | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT00552903 | ||||||
| Other Study ID Numbers ICMJE | PHKS-Z80 | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Dr Martti Talja, Päijät-Häme Health and Welfare Trust | ||||||
| Study Sponsor ICMJE | Paijat-Hame Hospital District | ||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Paijat-Hame Hospital District | ||||||
| Verification Date | February 2009 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||