Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582316
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Digital Solution for Salutogenic Brain Health DiSaB a Pilot Protocol for Clinical Implementation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Digital Solution for Salutogenic Brain Health DiSaB a Pilot Sequential Multiple Assignment Randomised Trial SMART Protocol for Clinical Implementation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DiSaB
Brief Summary:
The goal of this clinical trial is to develop and learn if a digitally delivered brain health intervention DiSaB can help improve cognitive physical and psychosocial health in middle-aged adults with chronic conditions at-risk for cognitive decline The clinical trial also aims to find out the push and pull factors of implementing the intervention in primary care settings The main questions it aims to answer are
1 Does the DiSaB intervention improve participants cognitive functions health measures and psychosocial health
2 Is an individualised or group-based health education session better at improving cognitive physical and psychosocial health in participants who did not respond to the DiSaB intervention
3 How useful and practical is the DiSaB intervention according to
1 participants and
2 nurses carrying out the intervention
The investigators will compare a DiSaB intervention to a control condition where participants do not undergo any intervention to see if the DiSaB intervention works in improving participants health
The investigators will also compare individualised versus group health education sessions to see which session is better at improving the health of participants who did not respond to the DiSaB intervention
Participants will
1 Complete cognitive assessments questionnaires and health tests before intervention immediately after the intervention and 6 months after the intervention
2 Either undergo no intervention or undergo the DiSaB intervention over 2 months
3 Be randomly selected to attend focus group interviews
Local champions will complete questionnaires and attend focus group interviews after administering andor co-facilitating the intervention
1 Does the DiSaB intervention improve participants cognitive functions health measures and psychosocial health
2 Is an individualised or group-based health education session better at improving cognitive physical and psychosocial health in participants who did not respond to the DiSaB intervention
3 How useful and practical is the DiSaB intervention according to
1 participants and
2 nurses carrying out the intervention
The investigators will compare a DiSaB intervention to a control condition where participants do not undergo any intervention to see if the DiSaB intervention works in improving participants health
The investigators will also compare individualised versus group health education sessions to see which session is better at improving the health of participants who did not respond to the DiSaB intervention
Participants will
1 Complete cognitive assessments questionnaires and health tests before intervention immediately after the intervention and 6 months after the intervention
2 Either undergo no intervention or undergo the DiSaB intervention over 2 months
3 Be randomly selected to attend focus group interviews
Local champions will complete questionnaires and attend focus group interviews after administering andor co-facilitating the intervention
Detailed Description:
The effectiveness of the DiSaB intervention implementation at primary care setting amongst participants with long term conditions will be evaluated using the Reach Effectiveness Adoption Implementation and Maintenance RE-AIM model
Secondly the barriers and facilitators to DiSaB implementation amongst local champions eg advanced practice nurses APNs will be determined Specifically using the Capability Opportunity Motivation and Behavior COM-B model the investigators will evaluate the barriers and facilitators towards DiSaB intervention implementation among healthcare professionals
Third sequential multiple assignment randomised trial SMART study design will also be employed in this study for the development of dynamic treatment regimens DTRs tailored for individual needs The investigators first aim to evaluate the feasibility and compare the efficacy of additional individual intervention ie a health education individual feedback session within 1 - 2 months vs a smaller group intervention ie health education group sessions over 3 months once per month post-standard TYB intervention amongst non-responders in improving cognitive functions and management of their long-term conditions Finally the investigators will compare two embedded DTRs in the SMART namely 1 standard TYB followed by individualised health education session for non-responders and usual care for responders and 2 standard TYB followed by group health education session for non-responders and usual care for responders
Lastly an economic evaluation will be carried out to evaluate cost-effectiveness and further impacts of the DiSaB implementation
Secondly the barriers and facilitators to DiSaB implementation amongst local champions eg advanced practice nurses APNs will be determined Specifically using the Capability Opportunity Motivation and Behavior COM-B model the investigators will evaluate the barriers and facilitators towards DiSaB intervention implementation among healthcare professionals
Third sequential multiple assignment randomised trial SMART study design will also be employed in this study for the development of dynamic treatment regimens DTRs tailored for individual needs The investigators first aim to evaluate the feasibility and compare the efficacy of additional individual intervention ie a health education individual feedback session within 1 - 2 months vs a smaller group intervention ie health education group sessions over 3 months once per month post-standard TYB intervention amongst non-responders in improving cognitive functions and management of their long-term conditions Finally the investigators will compare two embedded DTRs in the SMART namely 1 standard TYB followed by individualised health education session for non-responders and usual care for responders and 2 standard TYB followed by group health education session for non-responders and usual care for responders
Lastly an economic evaluation will be carried out to evaluate cost-effectiveness and further impacts of the DiSaB implementation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None