TV-based Service to Support People Living With Mild Dementia or Mild Cognitive Impariment

NCT03653234 | Completed

• 1 other identifier: TV-AssistDem (AAL-2016-024)
• Study Type: interventional
• Target: 404
• Locations: 2 countries
• Sites: 2

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.

Conditions

Mild Cognitive Impairment; Mild Dementia

Keywords

active and assisted living; assistive technology; telecare; remote consultations; informal caregivers; quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline and then at 6 and 12 months.

Secondary Outcomes (6)

• Change from baseline quality of life in informal caregivers at 6 and 12 months.

  At baseline and then at 6 and 12 months.

• Change from baseline burden in informal caregivers at 6 and 12 months.

  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.

  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.

  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.

  At baseline and then at 6 and 12 months.

Study Arms (2)

TV-based Assistive Integrated Service

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants assigned to the intervention group will NOT have access to TV-AssistDem and will participate in clinical visits every 6 months

Interventions

TV-based Assistive Integrated Service DEVICE

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.

TV-based Assistive Integrated Service

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead
• Îngrijiri la domiciliu, Romania: collaborator
• Consiglio Nazionale delle Ricerche, Italy: collaborator
• Institut multidisciplinaire de science de données, Italy: collaborator
• Asociación de Familiares de Personas con Alzheimer y otras Demencias de Málaga, Spain: collaborator
• Smart Health TV Solution, Spain: collaborator
• Istituto di Scienze e Tecnologie della Cognizione, Switzerland: collaborator
• MEDEA, Italy: collaborator

Study Sites (2)

Îngrijiri La Domiciliu

Brasov, 500177, Romania

Location

Instituto de Investigacion Biomedica de Malaga-IBIMA

Málaga, 29009, Spain

Location

Related Publications (20)

• Thorgrimsen L, Selwood A, Spector A, Royan L, de Madariaga Lopez M, Woods RT, Orrell M. Whose quality of life is it anyway? The validity and reliability of the Quality of Life-Alzheimer's Disease (QoL-AD) scale. Alzheimer Dis Assoc Disord. 2003 Oct-Dec;17(4):201-8. doi: 10.1097/00002093-200310000-00002.

  PMID: 14657783 BACKGROUND

• Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.

  PMID: 12021425 BACKGROUND

• Logsdon, R.G., Gibbons, L.E., McCurry, S.M., & Teri L. Quality of life in Alzheimer's disease: Patient and caregiver reports. J Ment Heal Aging. 1999;5(1):21-32.

  BACKGROUND

• Gomez-Gallego M, Gomez-Amor J, Gomez-Garcia J. [Validation of the Spanish version of the QoL-AD Scale in alzheimer disease patients, their carers, and health professionals]. Neurologia. 2012 Jan;27(1):4-10. doi: 10.1016/j.nrl.2011.03.006. Epub 2011 May 12. Spanish.

  PMID: 21570161 BACKGROUND

• Devlin NJ, Krabbe PF. The development of new research methods for the valuation of EQ-5D-5L. Eur J Health Econ. 2013 Jul;14 Suppl 1(Suppl 1):S1-3. doi: 10.1007/s10198-013-0502-3. No abstract available.

  PMID: 23900659 BACKGROUND

• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

  PMID: 21479777 BACKGROUND

• Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.

  PMID: 7203086 BACKGROUND

• Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.

  PMID: 11574710 BACKGROUND

• Sackett DL, Haynes RB, Gibson ES, Hackett BC, Taylor DW, Roberts RS, Johnson AL. Randomised clinical trial of strategies for improving medication compliance in primary hypertension. Lancet. 1975 May 31;1(7918):1205-7. doi: 10.1016/s0140-6736(75)92192-3.

  PMID: 48832 BACKGROUND

• Hansen RA, Kim MM, Song L, Tu W, Wu J, Murray MD. Comparison of methods to assess medication adherence and classify nonadherence. Ann Pharmacother. 2009 Mar;43(3):413-22. doi: 10.1345/aph.1L496. Epub 2009 Mar 3.

  PMID: 19261962 BACKGROUND

• Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.

  PMID: 3945130 BACKGROUND

• Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.

  PMID: 5349366 BACKGROUND

• Chisholm D, Knapp MR, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B. Client Socio-Demographic and Service Receipt Inventory--European Version: development of an instrument for international research. EPSILON Study 5. European Psychiatric Services: Inputs Linked to Outcome Domains and Needs. Br J Psychiatry Suppl. 2000;(39):s28-33. doi: 10.1192/bjp.177.39.s28.

  PMID: 10945075 BACKGROUND

• Beecham J, Knapp M. 12 Costing psychiatric interventions. In: G. Thornicroft, editor. Measuring Mental Health Needs. 2a. 2001. p. 200-24.

  BACKGROUND

• Brooke J. SUS : A Retrospective. J Usability Stud. 2013;8(2):29-40.

  BACKGROUND

• Bangor A, Kortum P, Miller J. Determining what individual SUS scores mean: Adding an adjective rating scale. J usability Stud. 2009;4(3):114-23.

  BACKGROUND

• Goeman D, Comans T, Enticott JC, Renehan E, Beattie E, Kurrle S, Koch S. Evaluating the Efficacy of the "Support for Life" Program for People with Dementia and Their Families and Carers' to Enable Them to Live Well: A Protocol for a Cluster Stepped Wedge Randomized Controlled Trial. Front Public Health. 2016 Oct 31;4:245. doi: 10.3389/fpubh.2016.00245. eCollection 2016.

  PMID: 27843893 BACKGROUND

• Woods RT, Orrell M, Bruce E, Edwards RT, Hoare Z, Hounsome B, Keady J, Moniz-Cook E, Orgeta V, Rees J, Russell I. REMCARE: Pragmatic Multi-Centre Randomised Trial of Reminiscence Groups for People with Dementia and their Family Carers: Effectiveness and Economic Analysis. PLoS One. 2016 Apr 19;11(4):e0152843. doi: 10.1371/journal.pone.0152843. eCollection 2016.

  PMID: 27093052 BACKGROUND

• Goodman-Casanova JM, Dura-Perez E, Guzman-Parra J, Cuesta-Vargas A, Mayoral-Cleries F. Telehealth Home Support During COVID-19 Confinement for Community-Dwelling Older Adults With Mild Cognitive Impairment or Mild Dementia: Survey Study. J Med Internet Res. 2020 May 22;22(5):e19434. doi: 10.2196/19434.

  PMID: 32401215 DERIVED

• Goodman-Casanova JM, Guzman-Parra J, Guerrero G, Vera E, Barnestein-Fonseca P, Cortellessa G, Fracasso F, Umbrico A, Cesta A, Toma D, Boghiu F, Dewarrat R, Triantafyllidou V, Tamburini E, Dionisio P, Mayoral F. TV-based assistive integrated service to support European adults living with mild dementia or mild cognitive impairment (TV-AssistDem): study protocol for a multicentre randomized controlled trial. BMC Geriatr. 2019 Sep 6;19(1):247. doi: 10.1186/s12877-019-1267-z.

  PMID: 31492113 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Fermín Mayoral Cleries

  Instituto de Investigación Biomédica de Malaga (IBIMA)-Fundacion FIMABIS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: August 31, 2018
• Study Start: April 1, 2019
• Primary Completion: August 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 14, 2021

Record last verified: 2020-05

Locations

RO (1); ES (1)