Evaluation of benefits of the CAREGIVERSPRO-MMD platform giving support and assistance to people living with dementia and their primary caregiver

Not Applicable

Completed

• Conditions: Mental and Behavioural Disorders; Unspecified dementia; Mild cognitive impairment or dementia (mild to moderate)

• Registration Number: ISRCTN15654731
• Lead Sponsor: niversitat Politècnica de Catalunya-BarcelonaTech (UPC)

Brief Summary

2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/31718279/ training methods (added 27/11/2020) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/31690170/ User engagement, usability and usefulness (added 27/10/2022) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/34187203/ Users' experiences, perceptions and support needs (added 27/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-06
• Study Completion: 2018-10-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1204

Inclusion Criteria

People living with mild cognitive impairment or dementia:
1. People, aged 50 and over, living in the community, who are able to give informed consent (or the legal tutor)
2. Diagnosed with mild cognitive impairment (MCI) according to Petersen criteria or mild to moderate dementia diagnosed according on DSM-IV criteria (Diagnostic and Statistical Manual, 4th edition)
3. Having a Clinical Dementia Rating (CDR) of 0.5 for MCI, 1-2 for mild to moderate dementia
4. Having a Mini-Mental Exam score (MMSE) between 30 and 25 (inclusive) for MCI, and between 24 and 10 (inclusive) for dementia
5. Having a primary caregiver, familiar (or not), informal (or not) identified and also included in the study
6. Be willing to use Information Technology and Communications (ICT) according to the investigator criteria

Primary caregivers:
1. People, aged 18 years and over, with no diagnosis or no evidence of mild cognitive impairment or mild to moderate dementia (according DSM-IV criteria), who are able to give informed consent and with an intention to complete the study
2. Primary caregivers, informal (or not), familiar (or not), of person with mild cognitive impairment or mild to moderate dementia
3. People with Internet access and basic knowledge and skills in managing internet and social networks, or keen to learn, according to the investigator criteria
4. Having a Geriatric Depression Scale (GDS-Yesavage - 15 items) score less than 11 at the time of entry into the trial indicating no severe depressive symptoms
5. Having no specific conditions (evaluated by the investigator) reducing their physical abilities below the norm for their age that would limit or impair CAREGIVERSPRO-MMD platform use
6. Be willing to use Information Technology and Communications (ICT) according to the investigator criteria

Exclusion Criteria

People with mild cognitive impairment and people living with dementia:
1. Terminal or severe illness with survival prognosis less than 18 months
2. Having delusions, hallucinations, behavioural disturbances, that may interfere with the use of Information and Communications Technology (ICT) tools
3. Relevant sensory problems (visual or hearing impairment) or motor disability (such as paralysis of upper limb or disabling arthritis or disabling tremor, etc) evaluated by the investigator that would interfere with the use of Information and Communications Technology (ICT) tools
4. Not speaking the language of the country where the pilot is being conducted

Primary caregivers:
1. Terminal or severe illness with survival prognosis less than 18 months
2. Relevant sensory problems (visual or hearing impairment) or motor disability (such as paralysis of upper limb or disabling arthritis or disabling tremor, etc) evaluated by the investigator that would interfere with the use of Information and Communications Technology (ICT) tools
3. Not speaking the language of the country where the pilot is being conducted

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> People living with mild cognitive impairment or dementia:<br> Quality of life, measured with the DEMQoL scale at baseline, 6, 12 and 18 months<br><br> Primary caregivers:<br> Perceived burden, measured with the ZBI scale at baseline, 6, 12 and 18 months<br>