Cognitive ImpairmentsNCT02746484
ABILITY - TelerehABILITation: TechnologY-enhanced Multi-domain at Home Continuum of Care Program
A study testing Ability platform program in people with Cognitive Impairments and Dementia, run by Fondazione Don Carlo Gnocchi ETS.
Trial summary
The Ability research project, funded in Italy within the Smart Cities and Smart Communities funding program (MInistry of University and Research, Operational Regional Programme, Lombardy, Axis 1, Operational Regional Programme - European Funding for Regional Development 2007-2013), aims at developing and testing the… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Cognitive Impairments, Dementia, Alzheimer Disease
- What is being tested?
- Ability platform program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- diagnosed as mild AD or MCI due to AD (Albert et al, 2011) according to DSM 5 diagnostic criteria (American Psychiatric Association, 2013);
- MMSE score >18
- school attendance (≥ 3 years).
Who cannot join
- dysmetria;
- serious deficits in visual acuity, acoustic perception, and in routine communication skills.
About this study
Official title: ABILITY - TelerehABILITation. TechnologY-enhanced Multi-domain at Home Continuum of Care Program for People With Cognitive Impairment.
The Ability research project, funded in Italy within the Smart Cities and Smart Communities funding program (MInistry of University and Research, Operational Regional Programme, Lombardy, Axis 1, Operational Regional Programme - European Funding for Regional Development 2007-2013), aims at developing and testing the efficacy and the impact of a Personal Smart Health Community able to provide innovative trajectories for people with cognitive impairment, putting them at the core of a continuous and intertwining treatment and support from both formal (e.g. physicians) and informal (e.g. near relatives) caregivers, with special focus on home-based care.
Within this framework of the Ability project the investigators test the efficacy of the home-based motor-cognitive rehabilitation program delivered with two different approaches: the Ability platform versus the usual care program
- Conditions
- Cognitive Impairments, Dementia, Alzheimer Disease
- Being tested
- Ability platform program, Usual care program
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ability platform programOther
The Ability program is an at home participant-tailored and technology-enhanced platform a) delivering tablet-based intensive (five days/a week for six weeks) motor and cognitive activities; b) monitoring from remote vital and physical health parameters (i.e., weight, Heart Rate, O2 saturation, daily steps, sleep activity).
Usual care programOther
Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)
| Study group | Role | What they receive |
|---|---|---|
| Ability platform program | Experimental | Multi-domain at home rehabilitation program delivered through the Ability platform. Receives: Other: Ability platform program |
| Usual care program | Active comparator | Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice) Receives: Other: Usual care program |
What is being measured
The primary outcome is the main question the study is designed to answer.
activities of daily living
Activities of Daily Living Inventory (ADCS/ADL)
Measured: change from baseline after 8 weeks (aMCI/AD subjects)
behavioral symptoms
Neuropsychiatric Inventory (NPI) score
Measured: change from baseline after 8 weeks (aMCI/AD subjects)
cognitive domain (long-term memory)
Free and Cued Selective Recall Test (FCSRT) score
Measured: change from baseline after 8 weeks (aMCI/AD subjects)
cognitive domain (language)
Fluency score
Measured: change from baseline after 8 weeks (aMCI/AD subjects)
cognitive domain (frontal-executive functions)
Trail Making Test (TMT) score
Measured: change from baseline after 8 weeks (aMCI/AD subjects)
quality of life
Dementia Quality of Life (D-QoL) Instrument
Measured: change from baseline after 8 weeks (aMCI/AD subjects)
coping strategies
Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
Measured: change from baseline after 8 weeks (aMCI/AD subjects)
global cognitive level
Montreal Cognitive Asssessment (MoCA) score
Measured: change from baseline after 12 months (aMCI/AD subjects)
Secondary outcomes (11)
activities of daily living
Activities of Daily Living Inventory (ADCS/ADL)
Measured: change from baseline after 12 months (aMCI/AD subjects)
conversion rate MCI versus AD
conversion rate score
Measured: change from baseline after 12 months (aMCI subjects)
cognitive domain - long term memory
Free and Cued Selective Recall Test (FCSRT) score
Measured: change from baseline after 12 months (aMCI/AD subjects)
cognitive domain - language
Fluency score
Measured: change from baseline after 12 months (aMCI/AD subjects)
cognitive domain - frontal executive functions
Trail Making Test (TMT) score
Measured: change from baseline after 12 months
quality of life
Dementia Quality of Life (D-QoL) Instrument
Measured: change from baseline after 12 months
coping strategies
Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
Measured: change from baseline after 12 months
caregiver quality of life
Psychological Well-Being (PWB) scale
Measured: change from baseline after 8 weeks and after 12 months
caregiver coping strategies
Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
Measured: change from baseline after 8 weeks and after 12 months
caregiver burden
Caregiver Burden Inventory (CBI)
Measured: change from baseline after 8 weeks and after 12 months
caregiver affect
Positive and Negative Affect Schedule (PANAS)
Measured: change from baseline after 8 weeks and after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startApr 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentsStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milano Bicocca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746484
- Sponsor's protocol ID
- FdG_AD_02
- Status last verified
- Jan 2017
- First submitted
- 12 Apr 2016
- Last updated
- 18 Jan 2017
- Results posted
- No
Publications
Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
PubMed 21514249Realdon O, Rossetto F, Nalin M, Baroni I, Cabinio M, Fioravanti R, Saibene FL, Alberoni M, Mantovani F, Romano M, Nemni R, Baglio F. Technology-enhanced multi-domain at home continuum of care program with respect to usual care for people with cognitive impairment: the Ability-TelerehABILITation study protocol for a randomized controlled trial. BMC Psychiatry. 2016 Nov 25;16(1):425. doi: 10.1186/s12888-016-1132-y.
PubMed 27887597
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABILITY - TelerehABILITation. TechnologY-enhanced Multi-domain at Home Continuum of Care Program for People With Cognitive Impairment.
- ClinicalTrials.gov ID
- NCT02746484
- Acronym / sponsor ID
- FdG_AD_02
- Conditions
- Cognitive Impairments, Dementia, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- University of Milano Bicocca
- Study start
- Apr 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Ability research project, funded in Italy within the Smart Cities and Smart Communities funding program (MInistry of University and Research, Operational Regional Programme, Lombardy, Axis 1, Operational Regional Programme - European Funding for Regional Development 2007-2013), aims at developing and testing the efficacy and the impact of a Personal Smart Health Community able to provide innovative trajectories for people with cognitive impairment, putting them at the core of a continuous and intertwining treatment and support from both formal (e.g. physicians) and informal (e.g. near relatives) caregivers, with special focus on home-based care.
Within this framework of the Ability project the investigators test the efficacy of the home-based motor-cognitive rehabilitation program delivered with two different approaches: the Ability platform versus the usual care program
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ability platform program | Experimental | Other: Ability platform programMulti-domain at home rehabilitation program delivered through the Ability platform. |
| Usual care program | Active comparator | Other: Usual care programUsual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice) |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- diagnosed as mild AD or MCI due to AD (Albert et al, 2011) according to DSM 5 diagnostic criteria (American Psychiatric Association, 2013);
- MMSE score >18
- school attendance (≥ 3 years).
Key exclusion criteria (2 listed)
- dysmetria;
- serious deficits in visual acuity, acoustic perception, and in routine communication skills.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ability platform programThe Ability program is an at home participant-tailored and technology-enhanced platform a) delivering tablet-based intensive (five days/a week for six weeks) motor and cognitive activities; b) monitoring from remote vital and physical health parameters (i.e., weight, Heart Rate, O2 saturation, daily steps, sleep activity). | Other | Ability platform program |
| Usual care programUsual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice) | Other | Usual care program |
Primary outcome
activities of daily living
Time frame: change from baseline after 8 weeks (aMCI/AD subjects)
Activities of Daily Living Inventory (ADCS/ADL)
behavioral symptoms
Time frame: change from baseline after 8 weeks (aMCI/AD subjects)
Neuropsychiatric Inventory (NPI) score
cognitive domain (long-term memory)
Time frame: change from baseline after 8 weeks (aMCI/AD subjects)
Free and Cued Selective Recall Test (FCSRT) score
cognitive domain (language)
Time frame: change from baseline after 8 weeks (aMCI/AD subjects)
Fluency score
cognitive domain (frontal-executive functions)
Time frame: change from baseline after 8 weeks (aMCI/AD subjects)
Trail Making Test (TMT) score
quality of life
Time frame: change from baseline after 8 weeks (aMCI/AD subjects)
Dementia Quality of Life (D-QoL) Instrument
coping strategies
Time frame: change from baseline after 8 weeks (aMCI/AD subjects)
Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
global cognitive level
Time frame: change from baseline after 12 months (aMCI/AD subjects)
Montreal Cognitive Asssessment (MoCA) score
11 secondary outcomes
activities of daily living
Time frame: change from baseline after 12 months (aMCI/AD subjects)
conversion rate MCI versus AD
Time frame: change from baseline after 12 months (aMCI subjects)
cognitive domain - long term memory
Time frame: change from baseline after 12 months (aMCI/AD subjects)
cognitive domain - language
Time frame: change from baseline after 12 months (aMCI/AD subjects)
cognitive domain - frontal executive functions
Time frame: change from baseline after 12 months
quality of life
Time frame: change from baseline after 12 months
coping strategies
Time frame: change from baseline after 12 months
caregiver quality of life
Time frame: change from baseline after 8 weeks and after 12 months
caregiver coping strategies
Time frame: change from baseline after 8 weeks and after 12 months
caregiver burden
Time frame: change from baseline after 8 weeks and after 12 months
caregiver affect
Time frame: change from baseline after 8 weeks and after 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Background: PubMed 21514249Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
- Derived from this study: PubMed 27887597Realdon O, Rossetto F, Nalin M, Baroni I, Cabinio M, Fioravanti R, Saibene FL, Alberoni M, Mantovani F, Romano M, Nemni R, Baglio F. Technology-enhanced multi-domain at home continuum of care program with respect to usual care for people with cognitive impairment: the Ability-TelerehABILITation study protocol for a randomized controlled trial. BMC Psychiatry. 2016 Nov 25;16(1):425. doi: 10.1186/s12888-016-1132-y.
Related trials for Cognitive Impairments
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ability platform program in people with Cognitive Impairments and Dementia, run by Fondazione Don Carlo Gnocchi ETS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
activities of daily living (time frame: change from baseline after 8 weeks (aMCI/AD subjects)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02746484, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.