An Integrated Solution for Sustainable Care for Multimorbid Elderly Patients With Dementia

NCT05104593 | Unknown

• 2 other identifiers: CAREPATH945169
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

The CAREPATH will conduct Technical Validation and Usability (TVU) study by involving ≥ 45 target end users (16 patients with MCI or mild dementia with their informal caregivers and 16 healthcare professionals from various disciplines) and Clinical Investigation (CI) study involving ≥ 200 patients (≥ 100 users to pilot the CAREPATH platform and ≥ 100 patients as reference cases). Both of these pilot studies will be coordinated in four European countries (Spain, Romania, Germany and UK) with diverse health and social care systems, ICT landscape/digital maturity of healthcare provision and dementia national programs, which will allow for strengthening the evidence base on health outcomes and efficiency gains. The CAREPATH outcomes can be summarized as:

1. 1.An Integrated Care Platform that jointly addresses multimorbidity, dementia and diminished intrinsic capacity and optimally manages healthcare interventions for its users (patients, informal caregiver, healthcare providers, etc).
2. 2.Technical Validation and Usability (TVU) study involving over 45 users and Clinical Investigation (CI) involving over 200 patients that will be conducted in four European countries (Spain, Romania, Germany and UK) during two years and mobilizing the other necessary actors, such as caregivers and healthcare professionals, for the validation of healthcare interventions.
3. 3.Dementia / Multimorbidity Guidelines that will be conceived for best healthcare delivery.
4. 4.Health Economics Impact Assessment for healthcare cost effectiveness and care provision equalities. The incremental cost-effectiveness and the incremental cost-utility ratio would allow revealing the incremental cost (or the potential savings) per unit of benefit of switching from usual care to CAREPATH-an integrated patient-centred approach- in multimorbid elderly patients with dementia, and therefore, to determinate whether the CAREPATH approach would be considered as a cost-effective alternative.

Conditions

Comorbidities and Coexisting Conditions; Alzheimer Disease; Dementia; Malnutrition; Frailty; Sarcopenia; Stroke; Asthma; Chronic Obstructive Pulmonary Disease; Chronic Kidney Diseases; Heart Failure; Diabetes; Coronary Artery Disease; Hypertension; Behavioral Symptoms

Keywords

Alzheimer Disease; Dementia; Quality of Life; Multimorbidity; Health monitoring; Home monitoring; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Change in healthcare appointments

  The following healthcare appointments will be recorded, including if they are scheduled or unscheduled, date, reason, actions taken and relationship with CAREPATH. Hospitalization Emergency visits Outpatient specialists visits at hospital or in polyclinics Primary care/General Practitioners medical visit Primary care nurse visit At-home medical visit At-home nurse visit Physiotherapist or occupational therapist visit Psychologist/Psychiatry visit Nutritionist/Dietist visit Radiology tests Lab analysis Other clinical tests

  1 year

Secondary Outcomes (4)

• Quality of Life (QoL)

  1 year

• Change in unplanned care

  1 year

• Change in inappropriate prescription

  1 year

• Change in number of participants with advanced directives

  1 year

Study Arms (2)

Intervention tested (CAREPATH)

EXPERIMENTAL

The intervention tested will be the CAREPATH system.

Other: Intervention tested (CAREPATH)

Control group

NO INTERVENTION

Control group, no intervention

Interventions

Intervention tested (CAREPATH) OTHER

The intervention tested will be the CAREPATH system. CAREPATH consists of an integrated, patient-centred, flexible and modular system that will provide a viable solution for the improvement of the management of multimorbid elderly patients with Mild Cognitive Impairment or mild dementia, with the help of clinicians. CAREPATH will act on patients and their informal caregivers, and its main objective is to empower multimorbid patients with MCI or mild dementia to manage their health condition together with their informal caregiver by providing assistance and reinforcement to follow their individual care plans, so independence and quality of life will increase for both of them. The intervention will provide a personalized care plan and activities proposal (treatment, activities proposal, lifestyle changes, referrals etc.) to patients and caregivers, considering the various sources of patient data available through the CAREPATH platform, and with the help of clinicians.

Intervention tested (CAREPATH)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Women and men aged ≥ 65 years old (randomization will warrant that at least 40% of each sex will be included in the study).
• Meets NIAAA core clinical criteria for probable Alzheimer disease, dementia or Mild Cognitive Impairment due to Alzheimer´s Disease (consistent with the NIAAA diagnostic criteria and guidelines for MCI; Albert MS, DeKosky ST, Dickson B, et al. The diagnosis of mild cognitive impairment due to Alzheimer's disease: Recommendations from the National Institute on Aging Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimer's \& Dement 2011; 7: 270-9)
• Mild symptomatology, as defined by a screening MMSE score of ≥ 22 points and CDR-GS of 0.5 or 1.0.
• Evidence of retrospective decline in cognitive functions.
• Multimorbidity: Presence of at least one of the following chronic diseases: Diabetes mellitus needing pharmacologic treatment, hypertension needing pharmacologic treatment, heart failure NYHA class 2-4, atrial fibrillation with a CHA2DS2-Vasc, chronic obstructive pulmonary disease (COPD) GOLD staging B-D, asthma needing pharmacologic treatment or chronic kidney disease (CKD) stage III-V.
• Living at home.
• Independence for basic activities of daily living.
• Availability of a person (referred to as the "caregiver" throughout this protocol) who in the investigator's judgment:
• Has frequent and sufficient contact with the patient to be able to provide accurate information regarding the patient's cognitive and functional abilities, agrees to provide information at clinic visits (which require partner input for scale completion), signs the necessary consent form, and has sufficient cognitive capacity to accurately report upon the patient's behavior and cognitive and functional abilities.
• Is in sufficiently good general health to have a high likelihood of maintaining the same level of interaction with the patient and participation in study procedures throughout the study duration.
• Note that every effort should be made to have same caregiver participate throughout the duration of the study.
• Fluency in the language used at the study site.
• Willingness and ability to complete all aspects of the study; the patient should be capable of completing assessments either alone or with the help of the caregiver.
• Adequate visual and auditory acuity, in the investigator's judgement, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted).
• Patient must have completed at least 6 years of formal education after the age of 5 years.

You may not qualify if:

• Any evidence of established dementia, including but not limited to, frontotemporal dementia, dementia with Lewy bodies, vascular dementia, Parkinson's disease, corticobasal degeneration, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal degeneration, Huntington's disease, normal pressure hydrocephalus, seizure disorder, or hypoxia. Presence of cerebral tumors, trauma, infections, autoimmune diseases or vitamin deficits (B12, folate…) affecting cognition.
• At risk of suicide in the opinion of the investigator.
• Inadequate home infrastructure to host the required technology.
• Inability to understand how to use the CAREPATH system.
• Illness that impedes carrying out the study:
• Active cancer of any type except non-melanoma skin cancer.
• Terminal disease (\<12 months of life expectancy).
• Other pathologies involving clinical instability.
• Psychiatric disorders or alcohol/drugs abuse.
• Living with a participant.
• Participation in other interventional clinical studies

Sponsors & Collaborators

• Complejo Hospitalario Universitario de Albacete: lead
• ECLEXYS SAGL: collaborator
• The Fraunhofer-Gesellschaft: collaborator
• Klinikum Bielefeld: collaborator
• University of Warwick: collaborator
• University Hospitals Coventry and Warwickshire NHS Trust: collaborator
• University of Castilla-La Mancha: collaborator
• CENTRUL IT PENTRU STIINTA SI TEHNOLOGIE: collaborator
• SRDC YAZILIM ARASTIRMA VE GELISTIRME VE DANISMANLIK TICARET ANONIM SIRKETI: collaborator
• OCTILIUM SAGL: collaborator

Study Sites (1)

Complejo Hospitalario Universitario de Albacete

Albacete, 02006, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Malnutrition; Frailty; Sarcopenia; Stroke; Asthma; Pulmonary Disease, Chronic Obstructive; Renal Insufficiency, Chronic; Heart Failure; Diabetes Mellitus; Coronary Artery Disease; Hypertension; Behavioral Symptoms

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Behavior

Central Study Contacts

Pedro Abizanda Soler, Dr

CONTACT

+34636557437; pabizanda@sescam.jccm.es

Almudena Avendaño Céspedes, Dr

CONTACT

+34967597684; aavendanoc@sescam.jccm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study is to be conducted in a simple-blind manner to minimize potential bias from investigators. It is not possible to conduct a double-blind study, because patients will know if they are using CAREPATH or not. In each site, two different investigators will be involved in the study. The first one will be responsible of initial assessments, randomization and management during follow-up. The investigator responsible of follow-up assessments for outcomes will be blinded to the assignment group in order to reduce the treatment effect bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomization will be performed centrally using a computerized system that uses stratified block randomization. After screening, patients who meet all eligibility criteria will be randomly assigned to 1 of 2 treatment groups (CAREPATH or control). Patients will be randomized in a CAREPATH to control ratio of 1:1. Randomization to intervention allocation will be stratified by sex, associated comorbidity and geographic region. Stratification factors will ensure balance of these factors across intervention arms and facilitate unbiased estimate of intervention effect in subgroups.

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 3, 2021
• Study Start: January 1, 2024
• Primary Completion: January 1, 2024
• Study Completion: December 31, 2025
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: At data Journal publication

Locations

ES (1)