Clinical trial NCT03653234: TV-based Service to Support People Living With Mild Dementia or Mild Cognitive Impariment
Official title: TV-based Assistive Integrated Service to Support European Adults Living With Mild Dementia or Mild Cognitive Impariment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Mild Dementia
Keywords: active and assisted living
assistive technology
telecare
remote consultations
informal caregivers
quality of life
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
Collaborators: name: Îngrijiri la domiciliu, Romania
name: Consiglio Nazionale delle Ricerche, Italy
name: Institut multidisciplinaire de science de données, Italy
name: Asociación de Familiares de Personas con Alzheimer y otras Demencias de Málaga, Spain
name: Smart Health TV Solution, Spain
name: Istituto di Scienze e Tecnologie della Cognizione, Switzerland
name: MEDEA, Italy
First posted: 2018-08-31
Enrollment: 404
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This multicentre randomized controlled trial aims to evaluate the effects of an intervention consisting of a TV-based Assistive Integrated Service developed to improve the quality of life in older people with mild cognitive impairment or mild dementia (PMCI/MD) and their informal caregivers. This study is a collaboration between four European countries (Spain, Romania, Italy and Switzerland) and the clinical trials will be conducted in two of these countries (Spain and Romania) In total 240 dyads, consisting of a person with mild cognitive impairment or mild dementia and their informal caregiver will be recruited for this study. Participant dyads will be randomized in a 1:1 ratio in two parallel groups: to receive either usual care from primary or specialized providers (control group) or to receive usual care plus access to a device with the Tv-AssistDem platform (intervention group).

Participants in the trial will be assessed for a period of 12 months. After the baseline visit, all participants will have follow-up visits every 6 months together with a checkup of the PMCI/MD capacity to remain in the study. In the follow up visits, investigators will assess the PMCI/MD quality of life, caregiver's quality of life and burden, patient treatment adherence, patient functional status and service utilization. A user-behaviour analysis and usability evaluation will also be performed.

Detailed description: TV-AssistDem is an interactive platform which has been designed and developed adapting the functionalities and content to best fit PMCI/MD, in a process involving the structured participation of PMCI/MD, their informal caregivers, and clinicians.

QUALITY ASSURANCE PLAN. The researchers will review and report the process during the trial covering participant enrolment, consent, eligibility and allocation to trial groups, policies to protect participants, including reporting of harm and completeness, accuracy and timeliness of data collection.

STANDARD OPERATING PROCEDURES. Participants will be recruited over a period of three months by physicians (primary care, psychiatry, neurology, and geriatrics), neuropsychologists and dementia and mental health nurses. Participants will not receive financial reimbursement for taking part in this trial. Participants will be identified from people with self- perceived cognitive impairment or caregiver´s perception of cognitive impairment that has been present for more than six months and who meet all the study eligibility criteria (listed in section Eligibility). The Mini-Mental State Examination (MMSE) and Geriatric Depression Scale (GDS-15) will be used to screen PMCI/MD at recruitment. Participants can be under primary care services as well as secondary care services. Participants will also be identified from patient databases such as those integrated in the network.

DATA DICTIONARY. All variables collected in this study are listed and described in an electronic case report form, with associated guidelines, to ensure consistency in all gathered data. The following data will be collected in this trial:

* Sociodemographical data.
* Medical history - PMCI/MD only.
* Quality of Life-Alzheimer's Disease Scale (QoL-AD Scale) (1-3).
* European Quality of Life 5 Dimensions 5 Levels (EuroQoL-5D-5L) (4,5).
* Zarit Burden Interview (ZBI-12) (6,7).
* Treatment adherence: Pill/dose count (8-10) and Morisky-Green Test (11).
* Functional decline: Lawton - Brody Instrumental Activities Of Daily Living Scale (IADL) (12).
* Service Utilisation: Client Service Receipt Inventory (CSRI) (13,14).
* Data from the TV-AssistDem application focusing on User-behaviour and usage of core services.
* Usability Evaluation: System Usability Scale (SUS) (15,16).

SAMPLE SIZE ASSESSMENT. The main outcome measure is the total score of the QoL-AD, which ranges from 13 to 52. According to recent studies (17,18) , the standard deviation of the total score of the QoL-AD is 7. For a minimum important clinical difference of 2.77 on the total QoL-AD score, with a standard deviation of 7, the effect size is 0.39.

To compare two groups (Intervention and Control) using a two- sample, two-sided t-test with a 5% statistical significance level, the minimum number of evaluable PMCI/MDs required in each group is 100 (200 overall), to give a power of 80%. If there would be a drop-out rate of 20% of the PMCI/MDs then the number of PMCI/MDs registered on the study would need to be 120 in each group (240 overall).

STATISTICS ANALYSIS PLAN. The flow of individuals will be shown schematically with counts and percentages in a CONSORT diagram. The analysis will be made following an intention-to-treat procedure. All variables collected will be summarized by group and by site at baseline and at final follow-up. Statistics considered for presentation for continuous measures in summary tables will be the mean, minima and maxima, and standard deviation, and if the criteria of normality are not met, the median and the first and third quartiles. Categorical variables will be summarized using counts and percentages. The baseline variables of the experimental group and the control group will be compared using the Chi-Square test for categorical variables and analysis of covariance for continuous variables.

For the primary outcome, a Linear Mixed Model analyses will be carried out as this approach is optimal to include subjects with missing data. First, an unadjusted analysis will be carried out and secondarily, in case that potentially confusing factors differ between the experimental group and the control group, despite the randomization, a supplementary multivariate analysis will be carried out. For secondary outcomes a Linear Mixed Model and Generalized Mixed Model analysis will be used for continuous and categorical variables respectively. Analysis will be two-tailed and alpha level set at 0.05.

ECONOMIC ANALYSIS. A cost-effectiveness and/or cost-utility analysis from a Health Service perspective (financer perspective) will be performed. The time horizon is two years and will include only direct costs. This refers to direct health costs (medication and healthcare use of services including outpatient and emergencies visits and hospital admissions). The Quality-Adjusted Life Years (QALYs) will be calculated to estimate the benefit calculating the utility improvement measure by EuroQoL-5D-5L.

USER-BEHAVIOUR ANALYSIS AND USABILITY EVALUATION. Data on various platform usage variables will be collected for the intervention group. Regression analysis will be used to assess the relationship between the primary and secondary outcome variables and the usage variables in order to indicate which aspects of the computer platform use most affect the outcomes. The results of the usability tests will be analyzed using statistical methods to quantify the error rate, effectiveness and learning curve of the TV-AssistDem platform.

PLAN FOR MISSING DATA. Each researcher is responsible for ensuring that any missing data will be reported as missing in the study database. Procedures can sometimes be considered when using statistical methods that fail in the presence of any missing values, or when in the case of multiple-predictor statistical models all the data for an individual would be omitted because of a missing value in one of the predictors. For analyses involving multiple regression analysis, a multiple imputation approach will be considered and used if statistically sound, depending on the proportion and pattern of missing values.

METHODS TO ENSURE VALIDITY AND QUALITY OF DATA. Accurate and reliable data collection will be assured by verification and cross-check of the case report form (CRF) against the researcher´s records (source document verification). Source document verification will be conducted for 5% of data in subjects. A comprehensive validation check program utilizing front-end checks in the CRF will verify these data. Discrepancies and queries will be generated accordingly in the CRF for online resolution by the researcher at the site. In addition, the CRF data will be reviewed on an ongoing basis for medical and scientific plausibility.

Eligibility criteria: Inclusion Criteria:

* Participants score 23-27 points on Mini-Mental State Examination (MMSE).
* Self-perceived cognitive impairment or caregiver´s perception of cognitive impairment that has been present for more than six months.
* Participants +60 years of age.
* Participants live independently.
* Participants have an informal caregiver.
* Participants who take prescribed medication are in charge of their own medication use.
* Participant with pharmacological treatment for a chronic conditions during study period.
* The place where the participant is normally resident has enough wireless or phone network connectivity to enable them to use Tv-AssistDem platform on a daily basis.
* Participants agree to be part of the study by giving signed written consent.

Exclusion Criteria:

* Participants have a terminal illness with \<3 years expected survival.
* Participants score above 11 on the Geriatric Depression Scale (GDS-15).
* Participants have specific conditions reducing their physical ability to use the application to a point that makes their participation in the project impossible (the nature of the conditions will be recorded in such cases).

Primary outcomes:
measure: Change from baseline quality of life in people with mild cognitive impairment or mild dementia at 6 and 12 months.
timeFrame: At baseline and then at 6 and 12 months.
Secondary outcomes:
measure: Change from baseline quality of life in informal caregivers at 6 and 12 months.
timeFrame: At baseline and then at 6 and 12 months.
measure: Change from baseline burden in informal caregivers at 6 and 12 months.
timeFrame: At baseline and then at 6 and 12 months.
measure: Change from baseline treatment adherence in people with mild cognitive impairment or mild dementia at 6 and 12 months.
timeFrame: At baseline and then at 6 and 12 months.
measure: Change from baseline treatment compliance in people with mild cognitive impairment or mild dementia at 6 and 12 months.
timeFrame: At baseline and then at 6 and 12 months.
measure: Change from baseline functional decline in people with mild cognitive impairment or mild dementia at 6 and 12 months.
timeFrame: At baseline and then at 6 and 12 months.
measure: Change from baseline healthcare costs at 12 months
timeFrame: At baseline and then at 12 months
Other outcomes:
Locations:
city: Brașov
country: Romania
facility: Îngrijiri La Domiciliu
city: Málaga
country: Spain
facility: Instituto de Investigacion Biomedica de Malaga-IBIMA
Study officials:
affiliation: Instituto de Investigación Biomédica de Malaga (IBIMA)-Fundacion FIMABIS
name: Fermín Mayoral Cleries
role: PRINCIPAL_INVESTIGATOR
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