TV-based Service to Support People Living With Mild Dementia or Mild Cognitive Impariment (TV-AssistDem)
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|ClinicalTrials.gov Identifier: NCT03653234|
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : August 9, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment Mild Dementia||Device: TV-based Assistive Integrated Service||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||TV-based Assistive Integrated Service to Support European Adults Living With Mild Dementia or Mild Cognitive Impariment|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: TV-based Assistive Integrated Service
Participants assigned to the intervention group will have access to TV-AssistDem and participate in clinical visits every 6 months.
Device: TV-based Assistive Integrated Service
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.
No Intervention: Control
Participants assigned to the intervention group will NOT have access to TV-AssistDem and will participate in clinical visits every 6 months
- Change from baseline quality of life in people with mild cognitive impairment or mild dementia at 6 and 12 months. [ Time Frame: At baseline and then 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.
- Change from baseline quality of life in informal caregivers at 6 and 12 months. [ Time Frame: At baseline and then 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.
- Change from baseline burden in informal caregivers at 6 and 12 months. [ Time Frame: At baseline and then 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).
- Change from baseline treatment adherence in people with mild cognitive impairment or mild dementia at 6 and 12 months. [ Time Frame: At baseline and then 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.
- Change from baseline treatment compliance in people with mild cognitive impairment or mild dementia at 6 and 12 months. [ Time Frame: At baseline and then 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.
- Change from baseline functional decline in people with mild cognitive impairment or mild dementia at 6 and 12 months. [ Time Frame: At baseline and then 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.
- Change from baseline healthcare costs at 12 months [ Time Frame: At baseline and then 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653234
|Contact: Fermín Mayoral Cleries, Phd, MDemail@example.com|
|Contact: Jessica M Goodman Casanova, BSNfirstname.lastname@example.org|
|Îngrijiri La Domiciliu||Recruiting|
|Brașov, Romania, 500177|
|Contact: Bianca Butnariu email@example.com|
|Instituto de Investigacion Biomedica de Malaga-IBIMA||Recruiting|
|Málaga, Spain, 29009|
|Contact: Fermín Mayoral Cleries, PhD, MD +34687952521 firstname.lastname@example.org|
|Contact: Jessica M Goodman Casanova, BSN +34660901966 email@example.com|
|Principal Investigator: Fermín Mayoral Cleries, PhD, MD|
|Sub-Investigator: Jessica M Goodman Casanova, BSN|
|Principal Investigator:||Fermín Mayoral Cleries||Instituto de Investigación Biomédica de Malaga (IBIMA)-Fundacion FIMABIS|