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Health coaching in primary health care for older people at moderate risk for cardiovascular diseases (CVD), diabetes and depression
ISRCTN ISRCTN01396033
DOI 10.1186/ISRCTN01396033
ClinicalTrials.gov identifier
EudraCT number
Public title Health coaching in primary health care for older people at moderate risk for cardiovascular diseases (CVD), diabetes and depression
Scientific title 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
Acronym N/A
Serial number at source N/A
Study hypothesis 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?
Lay summary Lay summary under review 2
Ethics approval The Regional Ethical Review Board in Umeå approved the study on 16th August 2011, ref: Dnr 2011-230-31
Study design Randomized controlled study
Countries of recruitment Sweden
Disease/condition/study domain Moderate risk for CVD, diabetes and depression in older people / promoting lifestyle change
Participants - inclusion criteria 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
Participants - exclusion criteria Potential participant that uses drugs linked to the inclusion criteria
Anticipated start date 01/10/2011
Anticipated end date 30/06/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 2000 (1500 in the intervention group and 500 in the control group)
Interventions 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.
Primary outcome measure(s) 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
Secondary outcome measure(s) 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
Sources of funding Swedish National Institute of Public Health (Sweden)
Trial website
Publications 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23497163
Contact name Prof  Lars  Lindholm
  Address Epidemiologi and Global health
Umeå University
  City/town Umeå
  Zip/Postcode SE 910 85
  Country Sweden
  Email lars.lindholm@epiph.umu.se
Sponsor Swedish National Institute of Public Health (Sweden)
  Address Forskarens väg 3
  City/town Östersund
  Zip/Postcode SE 83140
  Country Sweden
  Email sara.wamala@fhi.se
  Sponsor website: http://www.fhi.se/en/
Date applied 21/10/2011
Last edited 26/07/2013
Date ISRCTN assigned 24/11/2011
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