Viewing Study NCT03741543



Ignite Creation Date: 2024-05-06 @ 12:22 PM
Last Modification Date: 2024-10-26 @ 12:58 PM
Study NCT ID: NCT03741543
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-03-15
First Post: 2018-11-06

Brief Title: Learning and Coping With Early Stage Dementia
Sponsor: Helse Stavanger HF
Organization: Helse Stavanger HF

Study Overview

Official Title: Learning and Coping With Dementia - User Experiences From an Educative Intervention in Early Stage Dementia
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-09
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: The overall aim of this study is to investigate how home dwelling people with early-stage dementia cope with their disease explored through their participation in a 12-week health promotion course through 3 sub-studies 1 The users experience in gaining information about dementia and meeting others in the same situation 2 observation of the group interactions and support processes and 3 investigate the effect of the 12-week health promotion course for people with early stage dementia on their cognitive function psychosocial function and health behaviour
Detailed Description: In this study the investigators build on a health promotion intervention originally developed by Buettner and Fitzimmons 2009 called Health Promotion for the Mind Body and Spirit The Health Promotion intervention consists of 12 weekly 2-hour sessions Each group has up to 6 participants and the groups are facilitated by two professional group leaders The course has been designed to provide information on the disease process and on healthy behaviours to prevent problems that are common later in the disease The 12-week course includes nutrition cognitive fitness stress reduction communication information about the course of the disease and coping strategies During the first class session each participant received a nametag and a booklet This booklet is a critical component of the educational method for the participants The booklet contains 12 dividers for the 12 modules that the instructor taught during the course The caregiver is not present at the course however the participants are encouraged to share the booklet provided at the course with the caregiver between sessions

Design a quasi-experimental study with multiple methods

1 assessment of cognitive function psychosocial function and health behaviour is collected at baseline prior to attending the 12-week course and follow-up interviews are arranged shortly after the 12-week course For each participant a caregiver also has to take part for proxy interviews
2 the users experience of attending the 12-week health promotion course will be collected through qualitative individual interviews with the participants and their caregiver after attending the course
3 over the duration of the course a moderate participant observation will be carried out to explore changes over the 12-week course in-session behaviour social interaction and to capture motivational and empowering aspects of the course

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