About this trial
The purpose of The Brain Care Study is to investigate the prevalence of cognitive impairment in older adults with type 2 diabetes (T2D) and to evaluate the effectiveness of a multidomain intervention designed to prevent cognitive decline.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 65 years
Diagnosis of Type 2 Diabetes (T2D)
Patient at the outpatient clinic at either Bispebjerg Hospital, Rigshospitalet, or Steno Diabetes Center Copenhagen
Speaks and understands Danish (required for the cognitive tests)
Disqualifiers
Diagnosis of dementia or prior referral to a dementia clinic
Diagnosis of psychiatric, neurological, or other disorders that, in the investigator's opinion, hinder participation in cognitive screening, preclude compliance with the study protocol, or affect the evaluation of results
Meets all the above exclusion criteria
Participants whose cognitive MoCA screening indicates dementia will be excluded and advised to contact their physician
Trial design
Parallel
Treatments tested in this trial
Multidomain Intervention Targeting Cognitive Decline
Other interventionThe multidomain intervention will include the following: Optimization of pharmacological treatment/Pharmacological neuroprotection. Adjustment of HbA1c targets. Vascular risk factor management. Assessment of hearing impairment. Assessment of depression. Dialogue tools. Social interaction. Guidance on physical training. Cognitive training. Text message reminders.
Treatment groups
Trial outcomes
Primary outcomes
Difference in Change in Cognitive Function
Difference in change in cognitive function (visit 1 compared to follow-up) measured by SCIP between the multifactorial intervention group and the usual care group.
Secondary outcomes
The Number of Hospitalizations Related to All-cause Disease
Changes in Health-related Quality of Life Measured by SF-36
Sponsors and contacts
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