protocolSection identificationModule nctId: NCT06372002, orgStudyIdInfo id: 05/23, briefTitle: Effectiveness and Cost-Effectiveness of Cognitive Stimulation Therapy - Spain (CST-ES) in People Living With Dementia, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-16, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Instituto de Mayores y Servicios Sociales (IMSERSO), class: OTHER_GOV, collaborators name: University of Castilla-La Mancha, collaborators name: Confederación Española de Alzheimer (CEAFA), descriptionModule briefSummary: 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)., conditionsModule conditions: Dementia, conditions: Neurocognitive Disorders, conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The technician in charge of the evaluation of those participating in the study must be blinded throughout the CST intervention, i.e., he/she will not know whether the users being evaluated belong to the intervention or the control group.The CRE Alzheimer professional responsible for randomization and data analysis will also be blinded.The participants and the technician performing the intervention cannot be blinded due to the nature of the intervention., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 683, type: ACTUAL, armsInterventionsModule interventions name: Cognitive Stimulation Therapy (CST), outcomesModule primaryOutcomes measure: Cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG), primaryOutcomes measure: Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG), primaryOutcomes measure: Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG), primaryOutcomes measure: Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD), primaryOutcomes measure: Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD), primaryOutcomes measure: Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD), secondaryOutcomes measure: Cognitive functioning assessed through Mini-Mental State Examination (MMSE), secondaryOutcomes measure: Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE), secondaryOutcomes measure: Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE), secondaryOutcomes measure: Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L), secondaryOutcomes measure: Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L), secondaryOutcomes measure: Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L), otherOutcomes measure: Resource utilization evaluated through Resource Utilization in Dementia (RUD), otherOutcomes measure: Change in resource utilization evaluated through Resource Utilization in Dementia (RUD), otherOutcomes measure: Sociodemographic information gathered through the sociodemographic questionnaire, otherOutcomes measure: Adherence to the intervention and dropouts evaluated through a session form, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro de día de la Asociación de Familiares y Amigos de Enfermos de Alzheimer de Alcoy y Comarca, city: Alcoy, state: Alicante, country: Spain, geoPoint lat: 38.70545, lon: -0.47432, locations facility: AFA Castalla y Onil, city: Castalla, state: Alicante, country: Spain, geoPoint lat: 38.59694, lon: -0.67207, locations facility: AFA Elda, Petrer y Comarca del Medio Vinalopo, city: Elda, state: Alicante, country: Spain, geoPoint lat: 38.47783, lon: -0.79157, locations facility: AFA Teulada - Moraira (Marina Alta), city: Teulada, state: Alicante, country: Spain, geoPoint lat: 38.7294, lon: 0.10383, locations facility: Asociación Familiares de Personas con Alzheimer de Villena y Comarca, city: Villena, state: Alicante, country: Spain, geoPoint lat: 38.6373, lon: -0.86568, locations facility: Centro Terapéutico para Alzheimer y otras demencias "Antonia Blanco Sánchez", city: Mérida, state: Badajoz, country: Spain, geoPoint lat: 38.91611, lon: -6.34366, locations facility: Centro Alois II, city: Cornellà De Llobregat, state: Barcelona, country: Spain, geoPoint lat: 41.35, lon: 2.08333, locations facility: Asociación de familiares de personas con Alzheimer y otras demencias del Maresme, city: Mataró, state: Barcelona, country: Spain, geoPoint lat: 41.54211, lon: 2.4445, locations facility: Asociación de Familiares de Enfermos de Alzheimer de Iniesta (ADADI), city: Iniesta, state: Cuenca, country: Spain, geoPoint lat: 39.43333, lon: -1.75, locations facility: AFEAVA, city: Hervás, state: Cáceres, country: Spain, geoPoint lat: 40.27081, lon: -5.86721, locations facility: AFA Faro de Chipiona, city: Chipiona, state: Cádiz, country: Spain, geoPoint lat: 36.73663, lon: -6.43703, locations facility: Afa Puerto, city: El Puerto De Santa María, state: Cádiz, country: Spain, geoPoint lat: 36.59389, lon: -6.23298, locations facility: Asoc familiares de enfermos de Alzheimer y otras demencias afines de Fernán Núñez, city: Fernán Núñez, state: Córdoba, country: Spain, geoPoint lat: 37.67044, lon: -4.7264, locations facility: AFAMO, city: Montilla, state: Córdoba, country: Spain, geoPoint lat: 37.58627, lon: -4.63805, locations facility: AFASUR Genil, city: Puente Genil, state: Córdoba, country: Spain, geoPoint lat: 37.38943, lon: -4.76686, locations facility: Asociación de familiares de enfermos de Alzheimer de Motril - Contigo, city: Motril, state: Granada, country: Spain, geoPoint lat: 36.75066, lon: -3.5179, locations facility: AFAMA Pollença, city: Pollença, state: Islas Baleares, country: Spain, geoPoint lat: 39.87678, lon: 3.01626, locations facility: Asociación Alzheimer Bierzo, city: Ponferrada, state: León, country: Spain, geoPoint lat: 42.54664, lon: -6.59619, locations facility: Afa Santa Marina Del Rey, city: Santa Marina del Rey, state: León, country: Spain, geoPoint lat: 42.51334, lon: -5.86065, locations facility: Associació de Familiars i Malalts d'Alzheimer de Tàrrega i comarca, city: Tàrrega, state: Lleida, country: Spain, geoPoint lat: 41.64704, lon: 1.13957, locations facility: AFA Pozuelo, city: Pozuelo De Alarcón, state: Madrid, country: Spain, geoPoint lat: 40.43293, lon: -3.81338, locations facility: Asociación Alzheimer y otras Demencias Lorca, city: Lorca, state: Murcia, country: Spain, geoPoint lat: 37.67119, lon: -1.7017, locations facility: Centro de día Alzheimer Estepona, city: Estepona, state: Málaga, country: Spain, geoPoint lat: 36.42764, lon: -5.14589, locations facility: Centro de Día Nieves Barranco, city: Marbella, state: Málaga, country: Spain, geoPoint lat: 36.51543, lon: -4.88583, locations facility: AFADAX, city: Vélez-Málaga, state: Málaga, country: Spain, geoPoint lat: 36.78107, lon: -4.10266, locations facility: Asociación de Alzheimer "Virgen del Castillo", city: Lebrija, state: Sevilla, country: Spain, geoPoint lat: 36.92077, lon: -6.07529, locations facility: AFATA Asociación de familiares y amigos de personas con deterioro cognitivo, enfermedad de Alzheimer y otras demencias de Talavera de la Reina, city: Talavera De La Reina, state: Toledo, country: Spain, geoPoint lat: 39.96348, lon: -4.83076, locations facility: ASFAL (Asociación de Familiares y Amigos de personas con Alzheimer de Algemesí), city: Algemesí, state: Valencia, country: Spain, geoPoint lat: 39.19042, lon: -0.43572, locations facility: AFA Alginet, city: Alginet, state: Valencia, country: Spain, geoPoint lat: 39.26667, lon: -0.46667, locations facility: Centro de estimulación y Rehabilitación "La LLimera" de AFABALS, city: Benifayó, state: Valencia, country: Spain, geoPoint lat: 39.28439, lon: -0.42598, locations facility: AFA Benavente y Comarca, city: Benavente, state: Zamora, country: Spain, geoPoint lat: 42.00249, lon: -5.67826, locations facility: AFA Alicante, city: Alicante, country: Spain, geoPoint lat: 38.34517, lon: -0.48149, locations facility: Centre de Día AFA Barcelona, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Club de la memoria - Alzhei Cáceres, city: Cáceres, country: Spain, geoPoint lat: 39.47649, lon: -6.37224, locations facility: AFA Alzhe de Cadiz, city: Cádiz, country: Spain, geoPoint lat: 36.52672, lon: -6.2891, locations facility: Asociación San Rafael de Alzheimer y Otras Demencias, city: Córdoba, country: Spain, geoPoint lat: 37.89155, lon: -4.77275, locations facility: AFA Huelva, city: Huelva, country: Spain, geoPoint lat: 37.26638, lon: -6.94004, locations facility: Alzheimer León, city: León, country: Spain, geoPoint lat: 42.60003, lon: -5.57032, locations facility: Asociación de Familiares y Enfermos de Alzheimer y otras demencias de La Rioja (AFA Rioja), city: Logroño, country: Spain, geoPoint lat: 42.46667, lon: -2.45, locations facility: AFALU, city: Lugo, country: Spain, geoPoint lat: 43.00992, lon: -7.55602, locations facility: AFA Málaga, city: Málaga, country: Spain, geoPoint lat: 36.72016, lon: -4.42034, locations facility: Centro de Referencia estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso, city: Salamanca, zip: 37008, country: Spain, geoPoint lat: 40.96882, lon: -5.66388, locations facility: AGADEA, city: Santiago de Compostela, country: Spain, geoPoint lat: 42.88052, lon: -8.54569, locations facility: AFAV (Asociación Familiares Enfermos de Alzheimer Valencia), city: Valencia, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Alzheimer Ávila, city: Ávila, country: Spain, geoPoint lat: 40.65724, lon: -4.69951, locations facility: AFARABA, city: Gasteiz / Vitoria, state: Álava, country: Spain, geoPoint lat: 42.84998, lon: -2.67268, hasResults: False