Cognitive Screening and Multidomain Intervention Targeting Cognitive Decline in Type 2 Diabetes (The Brain Care Study)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSteno Diabetes Center Copenhagen

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Multidomain Intervention Targeting Cognitive Decline

    Other intervention

    The 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

420 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years

Secondary outcomes

1

The Number of Hospitalizations Related to All-cause Disease

Time frame
2 years
2

Changes in Health-related Quality of Life Measured by SF-36

Time frame
2 years

Other outcomes

Sponsors and contacts

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