Ignite Creation Date:
2024-05-06 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05181254
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2021-10-31
Brief Title:
HEAlth Dialogues for Patients With Mental Illness in Primary Care
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
Official Title:
HEAlth Dialogues for Patients With Mental Illness in Primary Care
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEAD-MIP
Brief Summary:
In the current project primary health care patients with mental illness such as anxiety depression fatigue or sleep disorders will be followed The study includes both health conversations with the health curve as a systematic work with lifestyle habits and the biochemical risk marker copeptin with a focus on improved lifestyle habits and the development of cardiovascular complications Participants will be followed up at 12 and 24 months with renewed health interview including the health curve and blood sampling National registries will be used for a up to 20 year long follow-up regarding cardiovascular complications and mortality
Detailed Description:
Patients with mental illness have an increased risk of cardiovascular morbidity and mortality compared to the rest of the population partly related to unhealthy lifestyle habits However not all risk factors for developing cardiovascular disease are known yet The interest in studies about the importance of copeptin as a biochemical risk factors has increased in recent years
Objectives
The main aim with this project is assessment of the effect of Health Dialogue with the health curve in swedish Hälsokurvan on lifestyle habits and cardiovascular risk factors in patients with mental illness in primary care The second aim is to assess copeptins prognostic value and to collect blood samples in a biobank for future research on molecular biomarkers with prognostic value for cardiovascular disease
Work plan
The study has a prospective observational design The method with Health Dialogues is previously validated in a Swedish context and is based on a detailed lifestyle questionnaire blood testing and personalized counselling by a trained health care professional The patients will be followed with a new Health Dialogue and blood samples after 12 and 24 months and for 20 years with National Registers
Significance
The effect of Health Dialogues in patients with mental illness is not studied yet The current fast implementation of the method in the primary care in south of Sweden the region of Scania provides a unique opportunity to study this patient group and the expected benefits of Health Dialogues in the long term to study a potentially useful risk biomarker copeptin as well as to build a biobank for future studies on cardiovascular prognostic risk markers
Objectives
The main aim with this project is assessment of the effect of Health Dialogue with the health curve in swedish Hälsokurvan on lifestyle habits and cardiovascular risk factors in patients with mental illness in primary care The second aim is to assess copeptins prognostic value and to collect blood samples in a biobank for future research on molecular biomarkers with prognostic value for cardiovascular disease
Work plan
The study has a prospective observational design The method with Health Dialogues is previously validated in a Swedish context and is based on a detailed lifestyle questionnaire blood testing and personalized counselling by a trained health care professional The patients will be followed with a new Health Dialogue and blood samples after 12 and 24 months and for 20 years with National Registers
Significance
The effect of Health Dialogues in patients with mental illness is not studied yet The current fast implementation of the method in the primary care in south of Sweden the region of Scania provides a unique opportunity to study this patient group and the expected benefits of Health Dialogues in the long term to study a potentially useful risk biomarker copeptin as well as to build a biobank for future studies on cardiovascular prognostic risk markers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None