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ISRCTN
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ISRCTN01396033
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ClinicalTrials.gov identifier
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Public title
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Health coaching in primary health care for older people at moderate risk for cardiovascular diseases (CVD), diabetes and depression
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Scientific title
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Health coaching in primary health care for older people at moderate risk for CVD, diabetes and depression: a randomized controlled trial in Sweden to promote healthier lifestyle with physical activity, better food and improved social life
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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One goal in the Swedish public health policy is to give “young older” people the possibility to live a long and healthy life. The overall aim of this study is to promote a better life style in order to live longer and healthier. The specific objectives are:
1. To give municipalities and county councils better knowledge of how they together with the informal sector can promote healthy aging
2. To increase the opportunities for older persons with moderate risk levels to get better health through health coaching conducted with motivational interviewing and subsequent activities.
The following research questions are in focus:
2.1. Are there some differences between the intervention group and the control group regarding health related quality of life?
2.2. Are there some differences between the intervention group and the control group regarding medical variables and self-reported lifestyle patterns?
2.3. Is the intervention cost effective?
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Lay summary
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Lay summary under review
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Ethics approval
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The Regional Ethical Review Board in Umeå approved the study on 16th August 2011, ref: Dnr 2011-230-31
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Study design
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Randomized controlled study
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Countries of recruitment
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Sweden
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Disease/condition/study domain
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Moderate risk for CVD, diabetes and depression in older people / promoting lifestyle change
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Participants - inclusion criteria
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Men and women between 60 and 75 are recruited to the study at the primary health care centre. Four counties in Sweden are selected and within these counties 21 health care centers have agreed to participate. All of them will enroll participants that fulfill one or more of the four individual inclusion criteria.
1. A minor increase of blood pressure that is not treated with drugs
2. A minor increase of blood sugar that is not treated with drugs
3. A minor depression that is not treated with drugs
4. An increase of waist-circumference
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Participants - exclusion criteria
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Potential participant that uses drugs linked to the inclusion criteria
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Anticipated start date
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01/10/2011
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Anticipated end date
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30/06/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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2000 (1500 in the intervention group and 500 in the control group)
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Interventions
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The study will compare patients which receive standard primary health care and patients that get standard care plus motivational talks (MI) that encourage the individuals to improve their lifestyle. The method is often referred to as MI (motivational interviewing) and will be conducted at baseline and after 3, 6, 12, and 18 month. 75% of the 2000 participants will be randomized to the intervention group and the rest will a control group receiving standard care. This implies that each county will recruit 500 participants of which 125 are randomized to the control group.
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Primary outcome measure(s)
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1. Blood pressure level at baseline and after 6, 12 and 18 month
2. Blood sugar level (Hba1c) at baseline and after 6, 12 and 18 month
3. Depression according to Montgomery-Asberg Depression Scale (MADRS) self rating scale at baseline and after 6, 12 and 18 month
4. Waist-circumference in cm at baseline and after 6, 12 and 18 month
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Secondary outcome measure(s)
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A questionaire with general and health related questions.
1. Section A- Background questions
2. Section B- Your social life
3. Section C- Life style questions
4. Section D- General health related questions including questions on drug use
5. Section E- EQ5D - including the Visual Analogue Scale (VAS) scale
6. Section F- Montgomery-Åsberg Depression Rating Scale (MADRS) scale on depression
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Sources of funding
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Swedish National Institute of Public Health (Sweden)
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Trial website
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Publications
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Contact name
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Prof
Lars
Lindholm
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Address
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Epidemiologi and Global health
Umeå University
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City/town
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Umeå
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Zip/Postcode
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SE 910 85
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Country
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Sweden
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Email
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lars.lindholm@epiph.umu.se
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Sponsor
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Swedish National Institute of Public Health (Sweden)
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Address
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Forskarens väg 3
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City/town
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Östersund
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Zip/Postcode
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SE 83140
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Country
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Sweden
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Email
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sara.wamala@fhi.se
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Sponsor website:
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http://www.fhi.se/en/
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Date applied
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21/10/2011
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Last edited
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24/11/2011
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Date ISRCTN assigned
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24/11/2011
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