Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404632
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-05
Brief Title:
A Group Intervention for Promoting Health-related Habits LEV-G
Sponsor:
Region Stockholm
Organization:
Region Stockholm
Study Overview
Official Title:
A Group Intervention for Promoting Health-related Habits in Individuals With Disabilities LEV-G
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
Health-related habits influences mental and physical health Still treatment of health-related habits which can help to remedy health problems is often not done at all or very superficially Multiple guidelines emphasize the importance of prioritizing health-related habits but there is a lack of implemented models To solve this the investigators have developed a transdiagnostic interprofessional material intended for several care settings The Lev-g intervention is intended for groups There is also an individual version of Lev that has its on registration in Clinical Trails
Detailed Description:
Lev is a brief transdiagnostic interprofessional intervention targeting health-related habits that is intended for several care settings The main population intended is individuals with neurodevelopmental disorders or parents or close relations to children with disabilities This study will therefore be open for participants recruited from several types of healthcare services in Sweden
Study 1 The feasibility trial investigates the following questions
Completion How many participants that started Lev completed the intervention What were the reasons for not not completing Lev How many sessions did the participants complete Lev includes screening Lev-s three sessions one booster session
Level of acceptability Was Lev perceived as creditable and satisfactory by healthcare workers and participants Treatment credibility will be measured before Lev and after the last session for both participants and healthcare workers Treatment satisfaction will be evaluated after each session and after the intervention is completed Session evaluations will be done by both participants and healthcare workers
Do the intervention lead to adverse events To what extent were individual goals met
Study 1 The feasibility trial investigates the following questions
Completion How many participants that started Lev completed the intervention What were the reasons for not not completing Lev How many sessions did the participants complete Lev includes screening Lev-s three sessions one booster session
Level of acceptability Was Lev perceived as creditable and satisfactory by healthcare workers and participants Treatment credibility will be measured before Lev and after the last session for both participants and healthcare workers Treatment satisfaction will be evaluated after each session and after the intervention is completed Session evaluations will be done by both participants and healthcare workers
Do the intervention lead to adverse events To what extent were individual goals met
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