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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
404
TV-AssistDem is an interactive platform which has been adapted specifically for people with MCI and mild dementia through a structured process. The application is intended to be used daily at home, mainly by the participants themselves, with the help of their informal caregivers. The device consists of an Android software and hardware TV (a Digital TV STB with Android technology). The core services of the platform are: 1) Calendar and reminders, 2) Health tracking and data transmission and 3) Videoconference; service-oriented applications are: 4) Cognitive stimulation (Stimulus© software); 5) Reminiscences; and 6) Patient and caregiver advice.
Îngrijiri La Domiciliu
Brasov, Romania
Instituto de Investigacion Biomedica de Malaga-IBIMA
Málaga, Spain
Change from baseline quality of life in people with mild cognitive impairment or mild dementia at 6 and 12 months.
Quality of Life-Alzheimer's Disease Scale (QoL-AD Scale) (1-3) is an instrument specifically designed to measure quality of life in people with dementia from the perspective of both the patient and the informal caregiver. It is a 13-item measure, which includes assessments of the person´s relationships with friends and family, financial situation, physical condition, mood, memory and an overall assessment of life quality. Response options are 4-point multiple choice options (1 = poor, 2= fair, 3= good, 4 = excellent). Scale scores range from 13 to 52, with higher scores indicating greater quality of life. PMCI/MD may lose cognitive function during the study to the extent that they are unable to complete the assessments themselves. For this reason, informal caregivers will also complete the QoL-AD, in parallel and on behalf of the PMCI/MD, from the start of the study.
Time frame: At baseline and then at 6 and 12 months.
Change from baseline quality of life in informal caregivers at 6 and 12 months.
European Quality of Life 5 Dimensions 5 Levels (EuroQoL-5D-5L) (4,5) is a standardized generic instrument consisting of a descriptive system and a visual analogue scale (VAS). The descriptive system comprises 5 dimensions covering mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A 1-digit number expresses the level selected for that dimension. The digits can be combined into a 5-digit number that describes the patient's health state. The VAS records the patient's self-rated health on a vertical scale, where the endpoints are 'The best health you can imagine' and 'The worst health you can imagine'. EuroQoL-5D-5L has been shown to correlate well with QoL-AD, indicating that using both measures side-by-side is compatible. Both will be completed by the patient and caregiver.
Time frame: At baseline and then at 6 and 12 months.
Change from baseline burden in informal caregivers at 6 and 12 months.
Zarit Burden Interview (ZBI-12) (6,7) is a 12-item scale with each answer chosen from a 5-point Likert scale (Nearly always=4, Quite frequently=3, Sometimes=2, Rarely=1, Never=0). It is a shortened version of the original scale, was developed specifically for informal caregivers of PMCI/MD and covers issues such as caregiver stress and the degree to which caring is affecting their health and social life. Total score range 0 to 48 (0-10= no to mild burden, 10-20= mild to moderate burden \>20= high burden).
Time frame: At baseline and then at 6 and 12 months.
Change from baseline treatment adherence in people with mild cognitive impairment or mild dementia at 6 and 12 months.
The dose/pill count (8-10) is the number of pills or doses taken divided by the prescribed ones, multiplied by 100 (expressed as a percentage). A good adherence is considered when the result of counting is between 80% (a twenty percent of doses/pills missed) and 110% (the patient takes ten percent more doses/pills) of dose/pill prescribed.
Time frame: At baseline and then at 6 and 12 months.
Change from baseline treatment compliance in people with mild cognitive impairment or mild dementia at 6 and 12 months.
The Morisky Green Test (11) consists of 4 contrast questions with dichotomous yes/no responses, reflecting the patient's behaviour regarding compliance. They are intended to assess whether the patient adopts correct attitudes regarding treatment for their disease; it is assumed that if the attitudes are incorrect the patient is non-compliant.
Time frame: At baseline and then at 6 and 12 months.
Change from baseline functional decline in people with mild cognitive impairment or mild dementia at 6 and 12 months.
Lawton Instrumental Activities of Daily Living (IADL) (12) is an interview format scale of 8-items covering instrumental activities, which are required for independent living: ability to use telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsability for own medications and ability to handle finances. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.
Time frame: At baseline and then at 6 and 12 months.
Change from baseline healthcare costs at 12 months
The Client Service Receipt Inventory (CSRI) (13,14) is an internationally used method for gathering data on service utilization and other domains relevant for economic analysis of mental health care. It has five sections: background client information, accommodation and living situation, employment history, earnings and benefits, a record of services usually used and information about informal caregiver support. The sections assessed will be consultations, admissions and visits in the last year, grouped into subsections according to hospital, specialist, primary or home care. Treatment related to hospital admissions or illness exacerbation will also be assessed. It´s adaptability ensures it is compatible with the research aims, context, participants' likely circumstances, and the quantity and precision of information required
Time frame: At baseline and then at 12 months
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