N/A
N=300
SAGE for the Early Detection of Cognitive Impairment at Primary Care Provider Visits
Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT04063371 ↗Enrolled (actual)
300
Serious AEs
—
Results posted
Jul 2021
Primary outcome: Primary: Number of Participants With a Diagnosis of a Cognitive Impairment Disorder Measured by Pharmacological Interventions for the Management of Cognitive Impairment. — 0; 0; 0 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Self-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE) (Other); Informant Conversation (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Diagnosis of a Cognitive Impairment Disorder Measured by Pharmacological Interventions for the Management of Cognitive Impairment. |
0; 0; 0 | — |
| PRIMARY Number of Participants in the Intervention and Control Groups With Any Referral for Further Evaluation/Management of Potential Cognitive Impairment |
2; 7; 0 | — |
| PRIMARY Number of Participants in the Intervention and the Control Groups With at Least One Follow-up Visit for Additional Investigation of a Cognitive Impairment Disorder. |
1; 4; 0 | — |
| SECONDARY Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment. |
1; 2; 0; 1; 4; 0 | — |
| SECONDARY Number of Participants With Pharmacological Interventions for the Management of the Cognitive Impairment in the Subgroups of the Intervention Arm With and Without Additional Inputs From Informants |
— | — |
| SECONDARY Scoring |
1; 1; 7; 13; 22; 25 | — |
| SECONDARY Questionnaires |
6; 1 | — |
Summary
Thus far no large randomized trial has demonstrated a correlation between screening and improved outcomes. This would need to be done to gain widespread acceptance of screening and case finding programs. Early detection of cognitive impairment could potentially result in the appropriate treatment of reversible cognitive impairment conditions or earlier initiation of pharmacological interventions for the management of a variety of other dementia or Mild Cognitive Impairment (MCI) conditions. A screening approach that reduces the number of false positive screens would improve the comfort level of physicians and patients with cognitive screening programs.
The investigators propose to use the Self-Administered Gerocognitive Examination (SAGE) and the Electronic Self-Administered Gerocognitive Examination (eSAGE) to identify patients who score in the cognitive impairment range during an office visit with their primary care provider. Conversation with an individual who knows the patient well (if possible) will be performed to ascertain a significant change in the patient's cognitive skills over the previous year. The investigators wish to determine if screening for cognitive impairment in this way leads to new diagnoses and management outcomes compared to a group of primary care providers who use their current usual method in screening for cognitive impairment during office visits.
Eligibility Criteria
Inclusion Criteria
- Adults 65-89 years of age who complete a non-acute care office visit.
Exclusion Criteria
- Diagnosis of mild cognitive impairment or dementia in the medical records.
- Diagnosis of visual loss or conditions causing visual loss in the medical records unless it is clear that the loss would not be sufficient to preclude reading standard medical forms with or without the use of visual aids.
Data sourced from ClinicalTrials.gov (NCT04063371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.