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

Multicentre pilot study to determine the benefits of CAREGIVERSPRO-MMD platform use based on the information and communications technology (ICT), dedicated to the support and assistance of dyads living with neurocognitive diseases including persons living with mild cognitive impairment or mild to moderate dementia and their primary caregivers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15654731
Enrollment
1204
Registered
2017-02-06
Start date
2017-01-01
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild cognitive impairment or dementia (mild to moderate) Mental and Behavioural Disorders Unspecified dementia

Interventions

Dyads (people living with mild cognitive impairment or dementia (mild to moderate) and their primary caregivers) are randomised into two groups: 1. A group using the CAREGIVERSPRO-MMD

Sponsors

Universitat Politècnica de Catalunya-BarcelonaTech (UPC)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
People living with mild cognitive impairment or dementia: Quality of life, measured with the DEMQoL scale at baseline, 6, 12 and 18 months Primary caregivers: Perceived burden, measured with the ZBI scale at baseline, 6, 12 and 18 months

Secondary

MeasureTime frame
People living with mild cognitive impairment or dementia: 1. Treatment adherence, measured with the MMAS-8 scale at baseline, 6, 12 and 18 months with telephone calls at 3, 9 and 15 months 2. Activities of daily living, measured with the IADL scale at baseline, 6, 12 and 18 months 3. Cognitive-clinical symptoms, measured the MMSE scale at baseline, 6, 12 and 18 months 4. Activities of daily living, measured with the BADL scale at baseline, 6, 12 and 18 months 5. Behavioural-psychological symptoms, measured with the GDS scale at baseline, 6, 12 and 18 months 6. Behavioural-psychological symptoms, measured with the NPI scale at baseline, 6, 12 and 18 months Primary caregivers: 1. Treatment adherence, measured with the MMAS-8 scale at baseline, 6, 12 and 18 months with telephone calls at 3, 9 and 15 months 2. Subjective quality of life, measured with the SF-36v2 scale at baseline, 6, 12 and 18 months 3. Behavioural-psychological symptoms, measured with the GDS scale at baseline, 6, 12 and 18 months 4. Behavioural-psychological symptoms, measured with the STAI scale at baseline, 6, 12 and 18 months 5. Perceived social support, measured with the MSPSS scale at baseline, 6, 12 and 18 months with telephone calls at 3, 9 and 15 months 6. Perceived success in relationships, measured with the FS scale at baseline, 6, 12 and 18 months with telephone calls at 3, 9 and 15 months Dyads: 1. Quality of the caregiving relationship, measured with the DAS scale at baseline, 6, 12 and 18 months

Countries

England, France, Italy, Spain, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026