Mild Cognitive Impairment and Multidomain Intervention Package
NCT Number: NCT06488430
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dementia
Interventions: BEHAVIORAL: Multidomain intervention package for preventing cognitive decline
Sponsor: University of Pittsburgh
Collaborators: Fogarty International Center of the National Institute of Health|Believers Church Medical College Hospital, Tiruvalla, Kerala, India
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 481
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-15
Completion Date: 2025-05-30
Locations: Believers Church Medical College, Tiruvalla, Kerala, 689 103, India

Summary:
The state of Kerala, India has the highest proportion of older adults and the burden of lifestyle diseases causes great concern. Therefore, there is need for identifying a feasible multidomain preventive intervention to ease this burden. Initially the burden of mild cognitive impairment will be determined as this information is scarce from the setting. A multidomain intervention package will be developed that is appropriate for the setting. The adherence rates, barriers and facilitators will be assessed. If the multidomain intervention is found feasible, it can be recommended for further clinical trials.

Primary Outcome Measures: Attention domain of Addenbrooke's Cognitive Examination-III (ACE-III)., Change in attention domain scores of Malayalam version of Addenbrooke's Cognitive Examination (m-ACE) will be tested after intervention (Score below the cut-off in at least one of the cognitive domains assessed.

\[One SD below the mean score (of that educational category) was taken as the cut-off for each domain\] The minimum score is 0 and maximum score is 18.

), Baseline, After one month intervention|Memory domain of Addenbrooke's Cognitive Examination-III (ACE-III)., Change in memory domain scores of Malayalam version of Addenbrooke's Cognitive Examination (m-ACE) will be tested after intervention (Score below the cut-off in at least one of the domains tested. The lowest score is 0 and highest score is \[One SD below the mean score (of that educational category) was taken as the cut-off for each domain\] The minimum score is 0 and maximum score is 26.

), Baseline, After one month intervention|Fluency domain of Addenbrooke's Cognitive Examination-III (ACE-III)., Change in fluency domain scores of Malayalam version of Addenbrooke's Cognitive Examination (m-ACE) will be tested after intervention (Score below the cut-off in at least one of the domains tested. The lowest score is 0 and highest score is 14.

\[One SD below the mean score (of that educational category) was taken as the cut-off for each domain\] The minimum score is 0 and maximum score is 18.

), Baseline, After one month intervention|Language domain of Addenbrooke's Cognitive Examination-III (ACE-III)., Change in language domain scores of Malayalam version of Addenbrooke's Cognitive Examination (m-ACE) will be tested after intervention (Score below the cut-off in at least one of the domains tested. The lowest score is 0 and highest score is 26.

\[One SD below the mean score (of that educational category) was taken as the cut-off for each domain\] The minimum score is 0 and maximum score is 18.

), Baseline, After one month intervention|Visuospatial domain of Addenbrooke's Cognitive Examination-III (ACE-III)., Change in visuospatial domain scores of Malayalam version of Addenbrooke's Cognitive Examination (m-ACE) will be tested after intervention (Score below the cut-off in at least one of the domains tested. The lowest score is 0 and highest score is 16.

\[One SD below the mean score (of that educational category) was taken as the cut-off for each domain\] The minimum score is 0 and maximum score is 18.

), Baseline, After one month intervention
Secondary Outcome Measures: Depression score on Geriatric Depression Scale, Persons with dementia will be enrolled and their depression score measured. Multidomain intervention package is provided for one months and depression score is measured again. The minimum score is 0 and maximum score is 30., Baseline and after one month intervention