Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372002
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-11
Brief Title:
Effectiveness and Cost-Effectiveness of Cognitive Stimulation Therapy - Spain CST-ES in People Living With Dementia
Sponsor:
Instituto de Mayores y Servicios Sociales IMSERSO
Organization:
Instituto de Mayores y Servicios Sociales IMSERSO
Study Overview
Official Title:
Effectiveness and Cost-Effectiveness of of Cognitive Stimulation Therapy - Spain CST-ES in People Living With Dementia A Randomized Controlled Multicenter Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
This study aims to evaluate the effectiveness and cost-effectiveness of CST-ES the Spanish adaptation of Cognitive Stimulation Therapy CST to improve cognition and quality of life in people with mild to moderate dementia
The evaluation will be conducted as a pragmatic multicenter randomized controlled clinical trial Participants will be randomized to receive 7 weeks of CST-ES followed by 24 weeks of maintenance CST-ES intervention group or to continue their usual treatment control group
The evaluation will be conducted as a pragmatic multicenter randomized controlled clinical trial Participants will be randomized to receive 7 weeks of CST-ES followed by 24 weeks of maintenance CST-ES intervention group or to continue their usual treatment control group
Detailed Description:
Spain is one of the countries with the most aged population due to the increase in life expectancy and the decrease in the birth rate As a result the number of people affected by age-related pathologies such as dementia has increased Dementia affects more than 700000 people in Spain and it is expected that this number will be nearly two million people by 2050 For this reason the Comprehensive Plan for Alzheimers Disease and Other Dementias 2019-2023 states that addressing dementia is a public health priority and a major social and health problem
To improve the quality of life of patients with dementia and their families a wide variety of non-pharmacological therapies NPT have been developed making cognitive interventions one of the most widespread Although in Spain the term cognitive stimulation is mostly used in a generic way that includes different intervention modalities at a conceptual level three types of cognitive interventions have been described cognitive stimulation cognitive training and cognitive rehabilitation In summary cognitive stimulation increases orientation and global cognitive status whilst cognitive training aims to restore specific cognitive functions and cognitive rehabilitation aims to preserve functionality in everyday contexts Although distinguishing between these cognition-oriented interventions is not always easy cognitive stimulation has probed the most efficacy with significant benefits on cognitive function compared to those obtained with acetylcholinesterase inhibitors and positive effects on quality of life well-being communication and social interaction
Cognitive Stimulation Therapy CST is a cognitive intervention for mild to moderate dementia that was developed in the United Kingdom and derived from those therapies that had shown the most promising results combining their most effective elements The original CST program consists of 14 45-minute sessions delivered twice a week for 7 weeks There is also a maintenance program that includes 24 additional sessions one session per week CST is thought to provide a positive environment with continuity and consistency between sessions to support memories formation Its key principles include person-centered attention consideration of the interests and abilities of every participant use of implicit rather than explicit learning focusing on opinions rather than facts stimulation of all senses and cognitive skills and use of reminiscence to orientate in the present moment CST focuses on the cognitive strengths of people with dementia reducing the sense of failure and increasing their confidence Positive reinforcement of questioning thinking and interacting can also lead to more positive self-evaluation increased communication and better use of cognitive skills in daily life
A manual has been published with the original CST intervention Making a Difference and another with the maintenance program Making a Difference 2 which includes the basic principles of the intervention each of the sessions developed details of the materials needed and how to monitor the process
CST has shown significant benefits in general cognitive function as well as improvements in specific cognitive functions such as communication and language memory orientation and praxis The program has also been shown to improve the quality of life of the participants In addition CST is effective independent of acetylcholinesterase inhibitor treatment and cognitive benefits are comparable to those obtained with this medication CST is a relatively unexpensive and more cost-effective intervention than usual care As a result of these findings CST has been recommended by organizations such as Alzheimers Disease International or the National Institute for Health and Clinical Excellence and the Social Care Institute for Excellence translated and adapted into several languages and offered in at least 35 countries
Although there is a significant amount of cognitive stimulation materials available in Spain none of the published programs has a level of evidence comparable to that of CST Given the need for evidence-based tools and materials to respond to the needs of people with dementia the National Reference Center for the Care of People with Alzheimers Disease and Other Dementias CREA has undertaken a process of translation and cultural adaptation of the two published CST manuals to the Spanish language and culture CST-ES Once the adaptation is completed a study protocol is developed to evaluate the effectiveness and cost-effectiveness of the CST-ES program to improve cognitive performance and quality of life in people with mild to moderate dementia Afterward a multicenter study will be conducted using a randomized clinical trial methodology
Hypothesis
After the 7 weeks of CST-ES participants in the intervention group will improve their cognitive scores whilst participants in the control group will either maintain or worsen their scores
Participants in the CST-ES group will improve their quality of life
Participants who continue with the CST-ES maintenance program will experience cognitive benefits compared to participants in the usual treatment control group
The CST-ES maintenance program will increase the quality-of-life benefits compared to the control group
Intervention with CST-ES and maintenance of CST-ES will be efficient compared to usual treatment
Objectives
The main objectives of the study are
To compare the effectiveness of CST-ES intervention followed by maintenance CST-ES with usual treatment to improve cognition and quality of life in people with mild to moderate dementia
The following is proposed as a secondary objective
Perform a cost-effectiveness and cost-utility analysis comparing the direct costs associated with CST-ES and usual treatment with the outcomes of the two alternatives
To improve the quality of life of patients with dementia and their families a wide variety of non-pharmacological therapies NPT have been developed making cognitive interventions one of the most widespread Although in Spain the term cognitive stimulation is mostly used in a generic way that includes different intervention modalities at a conceptual level three types of cognitive interventions have been described cognitive stimulation cognitive training and cognitive rehabilitation In summary cognitive stimulation increases orientation and global cognitive status whilst cognitive training aims to restore specific cognitive functions and cognitive rehabilitation aims to preserve functionality in everyday contexts Although distinguishing between these cognition-oriented interventions is not always easy cognitive stimulation has probed the most efficacy with significant benefits on cognitive function compared to those obtained with acetylcholinesterase inhibitors and positive effects on quality of life well-being communication and social interaction
Cognitive Stimulation Therapy CST is a cognitive intervention for mild to moderate dementia that was developed in the United Kingdom and derived from those therapies that had shown the most promising results combining their most effective elements The original CST program consists of 14 45-minute sessions delivered twice a week for 7 weeks There is also a maintenance program that includes 24 additional sessions one session per week CST is thought to provide a positive environment with continuity and consistency between sessions to support memories formation Its key principles include person-centered attention consideration of the interests and abilities of every participant use of implicit rather than explicit learning focusing on opinions rather than facts stimulation of all senses and cognitive skills and use of reminiscence to orientate in the present moment CST focuses on the cognitive strengths of people with dementia reducing the sense of failure and increasing their confidence Positive reinforcement of questioning thinking and interacting can also lead to more positive self-evaluation increased communication and better use of cognitive skills in daily life
A manual has been published with the original CST intervention Making a Difference and another with the maintenance program Making a Difference 2 which includes the basic principles of the intervention each of the sessions developed details of the materials needed and how to monitor the process
CST has shown significant benefits in general cognitive function as well as improvements in specific cognitive functions such as communication and language memory orientation and praxis The program has also been shown to improve the quality of life of the participants In addition CST is effective independent of acetylcholinesterase inhibitor treatment and cognitive benefits are comparable to those obtained with this medication CST is a relatively unexpensive and more cost-effective intervention than usual care As a result of these findings CST has been recommended by organizations such as Alzheimers Disease International or the National Institute for Health and Clinical Excellence and the Social Care Institute for Excellence translated and adapted into several languages and offered in at least 35 countries
Although there is a significant amount of cognitive stimulation materials available in Spain none of the published programs has a level of evidence comparable to that of CST Given the need for evidence-based tools and materials to respond to the needs of people with dementia the National Reference Center for the Care of People with Alzheimers Disease and Other Dementias CREA has undertaken a process of translation and cultural adaptation of the two published CST manuals to the Spanish language and culture CST-ES Once the adaptation is completed a study protocol is developed to evaluate the effectiveness and cost-effectiveness of the CST-ES program to improve cognitive performance and quality of life in people with mild to moderate dementia Afterward a multicenter study will be conducted using a randomized clinical trial methodology
Hypothesis
After the 7 weeks of CST-ES participants in the intervention group will improve their cognitive scores whilst participants in the control group will either maintain or worsen their scores
Participants in the CST-ES group will improve their quality of life
Participants who continue with the CST-ES maintenance program will experience cognitive benefits compared to participants in the usual treatment control group
The CST-ES maintenance program will increase the quality-of-life benefits compared to the control group
Intervention with CST-ES and maintenance of CST-ES will be efficient compared to usual treatment
Objectives
The main objectives of the study are
To compare the effectiveness of CST-ES intervention followed by maintenance CST-ES with usual treatment to improve cognition and quality of life in people with mild to moderate dementia
The following is proposed as a secondary objective
Perform a cost-effectiveness and cost-utility analysis comparing the direct costs associated with CST-ES and usual treatment with the outcomes of the two alternatives
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