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Not yet recruiting NCT07526480

Improving Dementia Care in Primary Practice

No phase Interventional Alzheimer Disease (AD) Mild Cognitive Impairment (MCI) Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Improving Dementia Care, Enhanced Usual Care.
Who it may be relevant to
Registry conditions: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI), Dementia. Basic parameters: from 66 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This clinical trial will evaluate a multi-level scalable intervention called Improving Dementia Care (IDC). The investigators hypothesize that IDC will increase dementia detection in patients with impaired cognition more than the control condition, Enhanced Usual Care (EUC), over 6 months.

Detailed description

This pilot RCT (N = 80) will evaluate the feasibility and effectiveness of a new multi-level intervention-Improving Dementia Care (IDC)-which aims to increase detection of Alzheimer disease (AD) in older primary care patients with impaired cognition. In IDC, investigators will screen older primary care patients for subjective cognitive concerns and objective cognitive impairment on the Telephone Interview for Cognitive Status (TICS). To eligible patients, the research team will deliver AD Education and Personalized Decision Counseling-eliciting values and goals to reach informed, preference-based decisions on whether to have an AD evaluation. In IDC, investigators will also send to primary care physicians (PCPs) the TICS results and a smart order set (i.e., orders for AD-relevant lab and neuroimaging) via the electronic health record (EHR). The research team posits that IDC-a patient-level and PCP-level intervention-will increase AD detection more than Enhanced Usual Care (EUC), which is usual care enhanced with sending the TICS results and smart order set to the PCPs of controls-solely a PCP-level intervention. At 6 months, investigators will compare IDC's vs. EUC's effectiveness to increase rates of: 1) Incident cognitive diagnoses (e.g., Mild Cognitive Impairment, AD); 2) Orders for AD-relevant lab and neuroimaging studies, 3) Completed AD-relevant lab and neuroimaging studies; 4) Prescribed AD medications; and 5) Referrals to AD specialists, masked to treatment assignment.

Interventions

  • Other Improving Dementia Care
    During a phone session, participants receive ADRD Education and Personalized Decision Counseling, which consists of eliciting values and goals to reach informed, preference-based decisions on whether to have an ADRD evaluation. Participants' primary care physicians are sent cognitive screening results and a smart order set (i.e., orders for ADRD-relevant lab and neuroimaging) via the electronic health record (EHR).
  • Other Enhanced Usual Care
    Usual care enhanced with notices sent to participants' primary care physicians with cognitive screening results and a smart order set (i.e., orders for ADRD-relevant lab and neuroimaging) via the electronic health record (EHR).

Primary outcome measures

  • Incident cognitive diagnoses. [Time frame: 6 months]
Secondary outcome measures (4)
  • Orders for Alzheimer's disease-relevant lab and neuroimaging [Time frame: 6 months]
  • Prescribed Alzheimer's disease (AD) medications. [Time frame: 6 months]
  • Referrals to Alzheimer's disease specialists [Time frame: 6 months]
  • Completed AD-relevant lab and neuroimaging studies [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • No previous diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease (AD).
  • Have a scheduled PCP visit in the next 4-6 weeks
  • Have subjective cognitive impairment
  • Score ≥ 26 on the Telephone Interview for Cognitive Status (TICS)

Exclusion criteria

  • EHR evidence or previous cognitive evaluations, diagnosis of MCI or AD, or use of AD medications
  • TICS score of ≤ 11.00
  • Inability to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07526480 · iRISID-2025-0888

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗