Effectiveness and Cost-Effectiveness of Cognitive Stimulation Therapy - Spain (CST-ES) in People Living With Dementia

Dementia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06372002
• Other study ID #: 05/23
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: Instituto de Mayores y Servicios Sociales (IMSERSO)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 700,000 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 Alzheimer's 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 Alzheimer's 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 Alzheimer's 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 683
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Users of any of the sites (Associations of Families of People with Dementia) participating in the study.
• Individuals with a clinical diagnosis of neurocognitive disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5; APA, 2013), including Alzheimer's Disease (AD), Vascular Dementia (VD), mixed dementia (MxD), Lewy Body Dementia (LBD), Frontotemporal Dementia (FTD), Mild cognitive impairment or dementia due to Parkinson's disease (PD).
• Mild cognitive impairment or mild to moderate dementia (MMSE greater than 10).
• People who can be able to communicate and understand enough to participate in group activities.
• People who can participate in a group activity for at least 45 minutes.
• Signing of informed consent by the person with dementia or the legal guardian.

Exclusion Criteria:

• Presence of sensory limitations that prevent participation in the sessions.
• Health problems that prevent or hinder their participation in the sessions.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment
• Neurocognitive Disorders

Intervention

Behavioral:
• Cognitive Stimulation Therapy (CST)
The intervention will consist of the Spanish adapted version of Cognitive Stimulation Therapy (CST) followed by the Maintenance CST program. CST is a cognitive intervention for treating mild to moderate dementia consisting of fourteen 45-minute group sessions that take place twice a week for 7 weeks. Each session follows a main topic (reminiscing about the person's life, current events, word games…) and is led by two group facilitators. The same structure is followed in every CST session: 1. Introduction (5 minutes). 2. Main Activity (25 minutes). 3. Closing (5 minutes). The Maintenance CST program follows the principles and structure of the original CST program and consists of 24 sessions, one per week, that will be administered after the original program. The topic, activities, and materials required for each session are specified in the CST-ES manuals, which also provide the key principles that should guide the intervention and other information necessary for its implementation.

Locations

Country	Name	City	State
Spain	Centro de día de la Asociación de Familiares y Amigos de Enfermos de Alzheimer de Alcoy y Comarca	Alcoy	Alicante
Spain	ASFAL (Asociación de Familiares y Amigos de personas con Alzheimer de Algemesí)	Algemesí	Valencia
Spain	AFA Alginet	Alginet	Valencia
Spain	AFA Alicante	Alicante
Spain	Alzheimer Ávila	Ávila
Spain	Centre de Día AFA Barcelona	Barcelona
Spain	AFA Benavente y Comarca	Benavente	Zamora
Spain	Centro de estimulación y Rehabilitación "La LLimera" de AFABALS	Benifayó	Valencia
Spain	Club de la memoria - Alzhei Cáceres	Cáceres
Spain	AFA Alzhe de Cadiz	Cádiz
Spain	AFA Castalla y Onil	Castalla	Alicante
Spain	AFA Faro de Chipiona	Chipiona	Cádiz
Spain	Asociación San Rafael de Alzheimer y Otras Demencias	Córdoba
Spain	Centro Alois II	Cornellà De Llobregat	Barcelona
Spain	Afa Puerto	El Puerto De Santa María	Cádiz
Spain	AFA Elda, Petrer y Comarca del Medio Vinalopo	Elda	Alicante
Spain	Centro de día Alzheimer Estepona	Estepona	Málaga
Spain	Asoc familiares de enfermos de Alzheimer y otras demencias afines de Fernán Núñez	Fernán Núñez	Córdoba
Spain	AFARABA	Gasteiz / Vitoria	Álava
Spain	AFEAVA	Hervás	Cáceres
Spain	AFA Huelva	Huelva
Spain	Asociación de Familiares de Enfermos de Alzheimer de Iniesta (ADADI)	Iniesta	Cuenca
Spain	Asociación de Alzheimer "Virgen del Castillo"	Lebrija	Sevilla
Spain	Alzheimer León	León
Spain	Asociación de Familiares y Enfermos de Alzheimer y otras demencias de La Rioja (AFA Rioja)	Logroño
Spain	Asociación Alzheimer y otras Demencias Lorca	Lorca	Murcia
Spain	AFALU	Lugo
Spain	AFA Málaga	Málaga
Spain	Centro de Día Nieves Barranco	Marbella	Málaga
Spain	Asociación de familiares de personas con Alzheimer y otras demencias del Maresme	Mataró	Barcelona
Spain	Centro Terapéutico para Alzheimer y otras demencias "Antonia Blanco Sánchez"	Mérida	Badajoz
Spain	AFAMO	Montilla	Córdoba
Spain	Asociación de familiares de enfermos de Alzheimer de Motril - Contigo	Motril	Granada
Spain	AFAMA Pollença	Pollença	Islas Baleares
Spain	Asociación Alzheimer Bierzo	Ponferrada	León
Spain	AFA Pozuelo	Pozuelo De Alarcón	Madrid
Spain	AFASUR Genil	Puente Genil	Córdoba
Spain	Centro de Referencia estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso	Salamanca
Spain	Afa Santa Marina Del Rey	Santa Marina del Rey	León
Spain	AGADEA	Santiago de Compostela
Spain	AFATA Asociación de familiares y amigos de personas con deterioro cognitivo, enfermedad de Alzheimer y otras demencias de Talavera de la Reina	Talavera De La Reina	Toledo
Spain	Associació de Familiars i Malalts d'Alzheimer de Tàrrega i comarca	Tàrrega	Lleida
Spain	AFA Teulada - Moraira (Marina Alta)	Teulada	Alicante
Spain	AFAV (Asociación Familiares Enfermos de Alzheimer Valencia)	Valencia
Spain	AFADAX	Vélez-Málaga	Málaga
Spain	Asociación Familiares de Personas con Alzheimer de Villena y Comarca	Villena	Alicante

Sponsors (3)

Lead Sponsor	Collaborator
Instituto de Mayores y Servicios Sociales (IMSERSO)	Confederación Española de Alzheimer (CEAFA), University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

References & Publications (34)

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Spector A, Orrell M, Davies S, Woods B. Can reality orientation be rehabilitated? Development and piloting of an evidence-based program of cognition-based therapies for people with dementia. Neuropsychol Rehabil. 2001; 11(3-4): 377-397. doi: 10.1080/09602010143000068.

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resource utilization evaluated through Resource Utilization in Dementia (RUD)	The Resource Utilization in Dementia (RUD) instrument is a standardized tool and the most widely used instrument for resource use data collection in dementia. The RUD assesses resource use of both patients and caregivers and consists of a baseline assessment and follow-up assessments. The RUD is administrated as an interview with the primary caregiver or other person with knowledge about the patient´s living situation.	Baseline (T0)
Other	Change in resource utilization evaluated through Resource Utilization in Dementia (RUD)	The Resource Utilization in Dementia (RUD) instrument is a standardized tool and the most widely used instrument for resource use data collection in dementia. The RUD assesses resource use of both patients and caregivers and consists of a baseline assessment and follow-up assessments. The RUD is administrated as an interview with the primary caregiver or other person with knowledge about the patient´s living situation.	24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)
Other	Sociodemographic information gathered through the sociodemographic questionnaire	The sociodemographic questionnaire was designed specifically for this study. It gathers information about the participants' gender, age, marital status, educational level, sensory deficit, diagnosis, and pharmacological treatment. It will be administered to all participants.	Baseline (T0)
Other	Adherence to the intervention and dropouts evaluated through a session form	Adherence to the intervention and dropouts will be assessed using a session form, designed specifically for this study, completed by the technician after each session, tracking the attendance and mood/behaviour of the participants throughout the intervention sessions.	After each of the intervention sessions
Primary	Cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)	The ADAS-Cog scale will be used, a test designed to assess cognition in people with AD. The ADAS-Cog takes approximately 30-40 minutes to complete and includes eleven tests that assess word recall, object and finger naming, verbal command comprehension, constructive praxis, ideational praxis, word recognition, expressive language, comprehension, and word finding difficulties. The maximum score is 70 points, and higher scores indicate greater severity of cognitive deficits. Due to its psychometric properties, it has been widely used in clinical pharmacological trials for AD to assess cognitive change throughout time.	Baseline (T0)
Primary	Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)	The ADAS-Cog scale will be used, a test designed to assess cognition in people with AD. The ADAS-Cog takes approximately 30-40 minutes to complete and includes eleven tests that assess word recall, object and finger naming, verbal command comprehension, constructive praxis, ideational praxis, word recognition, expressive language, comprehension, and word finding difficulties. The maximum score is 70 points, and higher scores indicate greater severity of cognitive deficits. Due to its psychometric properties, it has been widely used in clinical pharmacological trials for AD to assess cognitive change throughout time.	7 weeks after the start of the CST-ES program (First follow-up T1)
Primary	Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)	The ADAS-Cog scale will be used, a test designed to assess cognition in people with AD. The ADAS-Cog takes approximately 30-40 minutes to complete and includes eleven tests that assess word recall, object and finger naming, verbal command comprehension, constructive praxis, ideational praxis, word recognition, expressive language, comprehension, and word finding difficulties. The maximum score is 70 points, and higher scores indicate greater severity of cognitive deficits. Due to its psychometric properties, it has been widely used in clinical pharmacological trials for AD to assess cognitive change throughout time.	24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)
Primary	Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)	Quality of Life - Alzheimer's Disease (QoL-AD). QoL-AD is used to assess quality of life in people with dementia, based on the information provided by the patient (patient version). It consists of 13 items referring to perceived health status, mood, functional capacity, personal and leisure relationships, capacity to decide, and personal life as a whole. Each item is answered on a Likert-type scale from 1 (poor) to 4 (excellent). The score range from 13-52. Higher scores indicate better quality of life. This tool has good psychometric properties, and its use has been recommended by a European consensus to assess psychosocial interventions. The Spanish adaptation of this scale will be used.	Baseline (T0)
Primary	Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)	Quality of Life - Alzheimer's Disease (QoL-AD). QoL-AD is used to assess quality of life in people with dementia, based on the information provided by the patient (patient version). It consists of 13 items referring to perceived health status, mood, functional capacity, personal and leisure relationships, capacity to decide, and personal life as a whole. Each item is answered on a Likert-type scale from 1 (poor) to 4 (excellent). The score range from 13-52. Higher scores indicate better quality of life. This tool has good psychometric properties, and its use has been recommended by a European consensus to assess psychosocial interventions. The Spanish adaptation of this scale will be used.	7 weeks after the start of the CST-ES program (First follow-up T1)
Primary	Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)	Quality of Life - Alzheimer's Disease (QoL-AD). QoL-AD is used to assess quality of life in people with dementia, based on the information provided by the patient (patient version). It consists of 13 items referring to perceived health status, mood, functional capacity, personal and leisure relationships, capacity to decide, and personal life as a whole. Each item is answered on a Likert-type scale from 1 (poor) to 4 (excellent). The score range from 13-52. Higher scores indicate better quality of life. This tool has good psychometric properties, and its use has been recommended by a European consensus to assess psychosocial interventions. The Spanish adaptation of this scale will be used.	24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)
Secondary	Cognitive functioning assessed through Mini-Mental State Examination (MMSE)	Cognitive functioning assessed by the Mini-Mental State Examination (MMSE), a gold standard screening tool for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.	Baseline (T0)
Secondary	Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE)	Cognitive functioning assessed by the Mini-Mental State Examination (MMSE), a gold standard screening tool for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.	7 weeks after the start of the CST-ES program (First follow-up T1)
Secondary	Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE)	Cognitive functioning assessed by the Mini-Mental State Examination (MMSE), a gold standard screening tool for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.	24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)
Secondary	Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L)	EuroQol-5D 5-level version (EQ-5D-5L). The EQ-5D-5L is a generic instrument for the assessment of health-related quality of life that can be used in both relatively healthy individuals and in groups of patients with different disease conditions. The individual evaluates his or her own state of health first as severity levels by dimensions (mobility, self-care, daily activities, pain/ discomfort and anxiety/depression), and then using a more general evaluation visual analog scale (VAS). A third element is the social values index that is obtained for each health status generated by the instrument. The index ranges from 1 (best health status) to 0 (death), though there are negative values for the index, corresponding to those health statuses that are assessed as being worse than death. In this way, an index is obtained that can be used directly or combined with life years to calculate quality-adjusted life years (QALYs).	Baseline (T0)
Secondary	Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L)	EuroQol-5D 5-level version (EQ-5D-5L). The EQ-5D-5L is a generic instrument for the assessment of health-related quality of life that can be used in both relatively healthy individuals and in groups of patients with different disease conditions. The individual evaluates his or her own state of health first as severity levels by dimensions (mobility, self-care, daily activities, pain/ discomfort and anxiety/depression), and then using a more general evaluation visual analog scale (VAS). A third element is the social values index that is obtained for each health status generated by the instrument. The index ranges from 1 (best health status) to 0 (death), though there are negative values for the index, corresponding to those health statuses that are assessed as being worse than death. In this way, an index is obtained that can be used directly or combined with life years to calculate quality-adjusted life years (QALYs).	7 weeks after the start of the CST-ES program (First follow-up T1)
Secondary	Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L)	EuroQol-5D 5-level version (EQ-5D-5L). The EQ-5D-5L is a generic instrument for the assessment of health-related quality of life that can be used in both relatively healthy individuals and in groups of patients with different disease conditions. The individual evaluates his or her own state of health first as severity levels by dimensions (mobility, self-care, daily activities, pain/ discomfort and anxiety/depression), and then using a more general evaluation visual analog scale (VAS). A third element is the social values index that is obtained for each health status generated by the instrument. The index ranges from 1 (best health status) to 0 (death), though there are negative values for the index, corresponding to those health statuses that are assessed as being worse than death. In this way, an index is obtained that can be used directly or combined with life years to calculate quality-adjusted life years (QALYs).	24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)