Clinical trial NCT06372002: Effectiveness and Cost-Effectiveness of Cognitive Stimulation Therapy - Spain (CST-ES) in People Living With Dementia
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia
Neurocognitive Disorders
Mild Cognitive Impairment
Keywords: Dementia
Neurocognitive Disorders
Mild Cognitive Impairment
Cognitive stimulation
cognition
quality of life
neuropsychiatric symptoms
older adult
cognition oriented treatment
cost-effectiveness
Lead sponsor: Instituto de Mayores y Servicios Sociales (IMSERSO)
Sponsor class: OTHER_GOV
Collaborators: name: University of Castilla-La Mancha
name: Confederación Española de Alzheimer (CEAFA)
First posted: 2024-04-17
Enrollment: 683
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pragmatic, multicenter, randomized, controlled clinical trial is proposed to compare treatment with CST-ES followed by maintenance treatment with CST-ES with treatment as usual:

* First Phase: Participants who meet the inclusion criteria will be randomized to the CST-ES intervention group or a treatment-as-usual control group. Participants assigned to the intervention group will receive two sessions of CST-ES per week for 7 weeks, also they will continue their usual treatment. Participants in the control group will receive their usual treatment during the development of the study.
* Second Phase: After the first phase is completed, participants assigned to the intervention group will receive one session of maintenance CST-ES per week for 24 weeks besides continuing their usual treatment, whereas participants in the control group will continue their usual treatment during this second phase.
Primary purpose: TREATMENT

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).

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)
timeFrame: Baseline (T0)
measure: Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)
timeFrame: 7 weeks after the start of the CST-ES program (First follow-up T1)
measure: Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)
timeFrame: 24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)
measure: Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)
timeFrame: Baseline (T0)
measure: Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)
timeFrame: 7 weeks after the start of the CST-ES program (First follow-up T1)
measure: Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)
timeFrame: 24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)
Secondary outcomes:
measure: Cognitive functioning assessed through Mini-Mental State Examination (MMSE)
timeFrame: Baseline (T0)
measure: Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE)
timeFrame: 7 weeks after the start of the CST-ES program (First follow-up T1)
measure: Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE)
timeFrame: 24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)
measure: Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L)
timeFrame: Baseline (T0)
measure: Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L)
timeFrame: 7 weeks after the start of the CST-ES program (First follow-up T1)
measure: Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L)
timeFrame: 24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)
Other outcomes:
measure: Resource utilization evaluated through Resource Utilization in Dementia (RUD)
timeFrame: Baseline (T0)
measure: Change in resource utilization evaluated through Resource Utilization in Dementia (RUD)
timeFrame: 24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)
measure: Sociodemographic information gathered through the sociodemographic questionnaire
timeFrame: Baseline (T0)
measure: Adherence to the intervention and dropouts evaluated through a session form
timeFrame: After each of the intervention sessions
Locations:
city: Alcoy
country: Spain
facility: Centro de día de la Asociación de Familiares y Amigos de Enfermos de Alzheimer de Alcoy y Comarca
state: Alicante
city: Castalla
country: Spain
facility: AFA Castalla y Onil
state: Alicante
city: Elda
country: Spain
facility: AFA Elda, Petrer y Comarca del Medio Vinalopo
state: Alicante
city: Teulada
country: Spain
facility: AFA Teulada - Moraira (Marina Alta)
state: Alicante
city: Villena
country: Spain
facility: Asociación Familiares de Personas con Alzheimer de Villena y Comarca
state: Alicante
city: Mérida
country: Spain
facility: Centro Terapéutico para Alzheimer y otras demencias "Antonia Blanco Sánchez"
state: Badajoz
city: Cornellà De Llobregat
country: Spain
facility: Centro Alois II
state: Barcelona
city: Mataró
country: Spain
facility: Asociación de familiares de personas con Alzheimer y otras demencias del Maresme
state: Barcelona
city: Iniesta
country: Spain
facility: Asociación de Familiares de Enfermos de Alzheimer de Iniesta (ADADI)
state: Cuenca
city: Hervás
country: Spain
facility: AFEAVA
state: Cáceres
city: Chipiona
country: Spain
facility: AFA Faro de Chipiona
state: Cádiz
city: El Puerto De Santa María
country: Spain
facility: Afa Puerto
state: Cádiz
city: Fernán Núñez
country: Spain
facility: Asoc familiares de enfermos de Alzheimer y otras demencias afines de Fernán Núñez
state: Córdoba
city: Montilla
country: Spain
facility: AFAMO
state: Córdoba
city: Puente Genil
country: Spain
facility: AFASUR Genil
state: Córdoba
city: Motril
country: Spain
facility: Asociación de familiares de enfermos de Alzheimer de Motril - Contigo
state: Granada
city: Pollença
country: Spain
facility: AFAMA Pollença
state: Islas Baleares
city: Ponferrada
country: Spain
facility: Asociación Alzheimer Bierzo
state: León
city: Santa Marina del Rey
country: Spain
facility: Afa Santa Marina Del Rey
state: León
city: Tàrrega
country: Spain
facility: Associació de Familiars i Malalts d'Alzheimer de Tàrrega i comarca
state: Lleida
city: Pozuelo De Alarcón
country: Spain
facility: AFA Pozuelo
state: Madrid
city: Lorca
country: Spain
facility: Asociación Alzheimer y otras Demencias Lorca
state: Murcia
city: Estepona
country: Spain
facility: Centro de día Alzheimer Estepona
state: Málaga
city: Marbella
country: Spain
facility: Centro de Día Nieves Barranco
state: Málaga
city: Vélez-Málaga
country: Spain
facility: AFADAX
state: Málaga
city: Lebrija
country: Spain
facility: Asociación de Alzheimer "Virgen del Castillo"
state: Sevilla
city: Talavera De La Reina
country: Spain
facility: AFATA Asociación de familiares y amigos de personas con deterioro cognitivo, enfermedad de Alzheimer y otras demencias de Talavera de la Reina
state: Toledo
city: Algemesí
country: Spain
facility: ASFAL (Asociación de Familiares y Amigos de personas con Alzheimer de Algemesí)
state: Valencia
city: Alginet
country: Spain
facility: AFA Alginet
state: Valencia
city: Benifayó
country: Spain
facility: Centro de estimulación y Rehabilitación "La LLimera" de AFABALS
state: Valencia
city: Benavente
country: Spain
facility: AFA Benavente y Comarca
state: Zamora
city: Alicante
country: Spain
facility: AFA Alicante
city: Barcelona
country: Spain
facility: Centre de Día AFA Barcelona
city: Cáceres
country: Spain
facility: Club de la memoria - Alzhei Cáceres
city: Cádiz
country: Spain
facility: AFA Alzhe de Cadiz
city: Córdoba
country: Spain
facility: Asociación San Rafael de Alzheimer y Otras Demencias
city: Huelva
country: Spain
facility: AFA Huelva
city: León
country: Spain
facility: Alzheimer León
city: Logroño
country: Spain
facility: Asociación de Familiares y Enfermos de Alzheimer y otras demencias de La Rioja (AFA Rioja)
city: Lugo
country: Spain
facility: AFALU
city: Málaga
country: Spain
facility: AFA Málaga
city: Salamanca
country: Spain
facility: Centro de Referencia estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
city: Santiago de Compostela
country: Spain
facility: AGADEA
city: Valencia
country: Spain
facility: AFAV (Asociación Familiares Enfermos de Alzheimer Valencia)
city: Ávila
country: Spain
facility: Alzheimer Ávila
city: Gasteiz / Vitoria
country: Spain
facility: AFARABA
state: Álava
Study officials:
affiliation: CRE de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
name: Enrique Pérez-Sáez, Phd
role: STUDY_DIRECTOR
affiliation: University of Castilla-La Mancha
name: Luz María Peña Longobardo, Phd
role: PRINCIPAL_INVESTIGATOR
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