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SAGE for the Early Detection of Cognitive Impairment at Primary Care Provider Visits

Self-Administered Gerocognitive Examination (SAGE) for the Early Detection of Cognitive Impairment at Primary Care Provider Visits

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04063371
Enrollment
300
Registered
2019-08-21
Start date
2019-10-14
Completion date
2020-07-07
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment

Brief 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.

Detailed description

The Ohio State University Wexner Medical Center has over 100 primary care providers who see patients at 14 offices in central Ohio. These providers routinely see geriatric patients and routinely conduct Annual Wellness Visits. At least two primary care offices will be involved in this trial. At least one location will serve as the control office and will continue to conduct their visits including screening for cognitive impairment as they normally do using their usual method based on the primary care provider's normal practice. At least one different location will serve as the intervention office where all the providers, as their standard of care, use a standardized method for screening for cognitive impairment consisting of using the SAGE or eSAGE test and having a conversation with an individual who knows the patient well (if possible) to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year. Chart reviews will be conducted on all of the patients who meet the inclusion/exclusion criteria for the trial using a 60 day window from the initial visit. The demographics, medical history and list of current medications will be reviewed. SAGE or eSAGE test results and the primary care provider's opinion of the informant information regarding the patient's cognitive change over the previous year will be obtained. Additionally, the charts will be reviewed for the number of referrals for further evaluation/management of potential cognitive impairment (including lab work, neuroimaging, neuropsychology testing, neurology/psychiatry, occupational therapy, physical therapy, speech therapy, counseling, respite care, legal assistance (DPOA or living will), day care, home health, social work, financial planning, and cognitive research), the initiation of pharmacological interventions for the management of cognitive impairment and the diagnosis of cognitive impairment. Charts will also be screened to assess the number of follow up visits that were scheduled after the office visit for follow up regarding cognitive issues. For the intervention office, chart reviews will be conducted on patients who complete the SAGE or eSAGE and on patients who do not complete the SAGE or eSAGE. Possible reasons for why patients would not complete the SAGE or eSAGE include: time constraints, patient noncompliance and provider oversight. There will be 2 control groups. Control group 1 consists of primary care offices that did not use SAGE or eSAGE for any of their patients and Control group 2 consists of patients handled by the intervention office who did not complete the SAGE or eSAGE. Intervention group consists of patients handled by the intervention office who did complete the SAGE or eSAGE. SAGE and eSAGE test scoring will be compared between the intervention office and the research site. Upon completion of the trial, the providers from the intervention group will be requested to complete a questionnaire to evaluate the practicality and ease of use of the SAGE and eSAGE test.

Interventions

OTHERSelf-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE)

The Self-Administered Gerocognitive Examination (SAGE) is a reliable and valid assessment that is used to detect MCI and early dementia. It is a pen and paper assessment that has 4 interchangeable versions. The digital version of SAGE (eSAGE; commercially known as BrainTest®) is made for tablet use, consists of the identical test questions as SAGE, and is strongly associated with the validated SAGE.

OTHERInformant Conversation

If possible, the provider will have a conversation with an individual who knows the patient will to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year.

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to 89 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With a Diagnosis of a Cognitive Impairment Disorder Measured by Pharmacological Interventions for the Management of Cognitive Impairment.60 daysNumber of participants in the intervention and the two control groups with diagnosis of a cognitive impairment disorder as measured by pharmacological interventions for the management of cognitive impairment.
Number of Participants in the Intervention and Control Groups With Any Referral for Further Evaluation/Management of Potential Cognitive Impairment60 daysNumber of participants in the intervention and the two control groups with any referral for further evaluation/management of potential cognitive impairment.
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.60 daysNumber of participants in the intervention and the two control groups with at least one follow-up visit for additional investigation of a cognitive impairment disorder.

Secondary

MeasureTime frameDescription
Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.60 daysNumber of referrals used for subjects in the intervention and two control groups for further evaluation/management of potential cognitive impairment.
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 Informants60 daysNumber of participants with pharmacological interventions for the management of the cognitive impairment in the two subgroups of the intervention arm with and without additional inputs from informants
Scoring60 daysDifferences of SAGE and eSAGE scoring between intervention office and research site.
Questionnaires60 daysResults of the questionnaire to evaluate the practicality and ease of use of the SAGE and eSAGE test by primary care providers and staff.

Countries

United States

Participant flow

Participants by arm

ArmCount
Control Group 1
At least one location will serve as the control office and will continue to conduct their visits including screening for cognitive impairment as they normally do using their usual method based on the primary care provider's normal practice.
100
Intervention Group
At least one different location will serve as the intervention office where all the providers, as their standard of care, use a standardized method for screening for cognitive impairment consisting of using the SAGE or eSAGE test and having a conversation with an individual who knows the patient well (if possible) to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year. Self-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE): The Self-Administered Gerocognitive Examination (SAGE) is a reliable and valid assessment that is used to detect MCI and early dementia. It is a pen and paper assessment that has 4 interchangeable versions. The digital version of SAGE (eSAGE; commercially known as BrainTest®) is made for tablet use, consists of the identical test questions as SAGE, and is strongly associated with the validated SAGE. Informant Conversation: If possible, the provider will have a conversation with an individual who knows the patient will to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year.
100
Control Group 2
Control group 2 consists of patients handled by the intervention office who did not complete the SAGE or eSAGE.
100
Total300

Baseline characteristics

CharacteristicControl Group 1Intervention GroupControl Group 2Total
Age, Continuous70.0781 years71.46759 years71.53598 years70.88031 years
Race/Ethnicity, Customized
African American
10 participants16 participants22 participants48 participants
Race/Ethnicity, Customized
Caucasian
82 participants83 participants74 participants239 participants
Race/Ethnicity, Customized
Other
8 participants1 participants4 participants13 participants
Region of Enrollment
United States
100 participants100 participants100 participants300 participants
Sex: Female, Male
Female
57 Participants58 Participants67 Participants182 Participants
Sex: Female, Male
Male
43 Participants42 Participants33 Participants118 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

Primary

Number of Participants in the Intervention and Control Groups With Any Referral for Further Evaluation/Management of Potential Cognitive Impairment

Number of participants in the intervention and the two control groups with any referral for further evaluation/management of potential cognitive impairment.

Time frame: 60 days

ArmMeasureValue (NUMBER)
Control Group 1Number of Participants in the Intervention and Control Groups With Any Referral for Further Evaluation/Management of Potential Cognitive Impairment2 participants
Intervention GroupNumber of Participants in the Intervention and Control Groups With Any Referral for Further Evaluation/Management of Potential Cognitive Impairment7 participants
Control Group 2Number of Participants in the Intervention and Control Groups With Any Referral for Further Evaluation/Management of Potential Cognitive Impairment0 participants
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.

Number of participants in the intervention and the two control groups with at least one follow-up visit for additional investigation of a cognitive impairment disorder.

Time frame: 60 days

ArmMeasureValue (NUMBER)
Control Group 1Number 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 participants
Intervention GroupNumber of Participants in the Intervention and the Control Groups With at Least One Follow-up Visit for Additional Investigation of a Cognitive Impairment Disorder.4 participants
Control Group 2Number of Participants in the Intervention and the Control Groups With at Least One Follow-up Visit for Additional Investigation of a Cognitive Impairment Disorder.0 participants
Primary

Number of Participants With a Diagnosis of a Cognitive Impairment Disorder Measured by Pharmacological Interventions for the Management of Cognitive Impairment.

Number of participants in the intervention and the two control groups with diagnosis of a cognitive impairment disorder as measured by pharmacological interventions for the management of cognitive impairment.

Time frame: 60 days

ArmMeasureValue (NUMBER)
Control Group 1Number of Participants With a Diagnosis of a Cognitive Impairment Disorder Measured by Pharmacological Interventions for the Management of Cognitive Impairment.0 participants
Intervention GroupNumber of Participants With a Diagnosis of a Cognitive Impairment Disorder Measured by Pharmacological Interventions for the Management of Cognitive Impairment.0 participants
Control Group 2Number of Participants With a Diagnosis of a Cognitive Impairment Disorder Measured by Pharmacological Interventions for the Management of Cognitive Impairment.0 participants
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

Number of participants with pharmacological interventions for the management of the cognitive impairment in the two subgroups of the intervention arm with and without additional inputs from informants

Time frame: 60 days

Population: Since no participants were started on pharmacological interventions for the management of cognitive impairment (results of primary outcome measure 1) this outcome measure was not applicable. No data was analyzed since the subgroup in question did not exist. 100 subjects in each group were analyzed for primary outcome measure #1. This secondary outcome measure was intended to further analyze the subgroup. 0 is entered for these results since the subgroup did not exist.

Secondary

Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.

Number of referrals used for subjects in the intervention and two control groups for further evaluation/management of potential cognitive impairment.

Time frame: 60 days

Population: The referrals that were investigated are listed in the rows below.100 subjects were analyzed in each group, but primary outcome measure 2 lists the total number of subjects in each group that had referrals. This secondary outcome measure lists the breakdown of the referrals. Some subjects had multiple referrals.

ArmMeasureGroupValue (NUMBER)
Control Group 1Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.occupational therapy0 participants
Control Group 1Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.Neuroimaging1 participants
Control Group 1Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.neuropsychological testing0 participants
Control Group 1Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.neurology/psychiatry2 participants
Control Group 1Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.Lab work1 participants
Control Group 1Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.physical therapy0 participants
Control Group 1Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.speech therapy0 participants
Control Group 1Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.counseling0 participants
Control Group 1Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.respite care0 participants
Control Group 1Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.legal assistance0 participants
Control Group 1Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.day care0 participants
Control Group 1Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.home health0 participants
Control Group 1Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.social work0 participants
Control Group 1Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.financial planning0 participants
Control Group 1Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.cognitive research0 participants
Control Group 1Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.other1 participants
Intervention GroupNumber of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.physical therapy0 participants
Intervention GroupNumber of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.speech therapy0 participants
Intervention GroupNumber of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.counseling3 participants
Intervention GroupNumber of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.financial planning1 participants
Intervention GroupNumber of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.respite care0 participants
Intervention GroupNumber of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.legal assistance2 participants
Intervention GroupNumber of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.other6 participants
Intervention GroupNumber of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.day care0 participants
Intervention GroupNumber of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.Lab work2 participants
Intervention GroupNumber of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.cognitive research0 participants
Intervention GroupNumber of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.Neuroimaging4 participants
Intervention GroupNumber of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.home health2 participants
Intervention GroupNumber of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.neuropsychological testing0 participants
Intervention GroupNumber of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.neurology/psychiatry4 participants
Intervention GroupNumber of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.occupational therapy0 participants
Intervention GroupNumber of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.social work1 participants
Control Group 2Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.day care0 participants
Control Group 2Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.physical therapy0 participants
Control Group 2Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.social work0 participants
Control Group 2Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.neuropsychological testing0 participants
Control Group 2Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.speech therapy0 participants
Control Group 2Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.other0 participants
Control Group 2Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.Lab work0 participants
Control Group 2Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.counseling0 participants
Control Group 2Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.home health0 participants
Control Group 2Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.occupational therapy0 participants
Control Group 2Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.respite care0 participants
Control Group 2Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.financial planning0 participants
Control Group 2Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.Neuroimaging0 participants
Control Group 2Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.legal assistance0 participants
Control Group 2Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.neurology/psychiatry0 participants
Control Group 2Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.cognitive research0 participants
Secondary

Questionnaires

Results of the questionnaire to evaluate the practicality and ease of use of the SAGE and eSAGE test by primary care providers and staff.

Time frame: 60 days

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Control Group 1QuestionnairesWould recommend the SAGE test during office visits for other colleagues6 Participants
Control Group 1QuestionnairesWould not recommend the SAGE test during office visits for other colleagues1 Participants
Secondary

Scoring

Differences of SAGE and eSAGE scoring between intervention office and research site.

Time frame: 60 days

Population: Only the SAGE was utilized in this trial. eSAGE was not utilized. 93 SAGEs were graded by the providers. The others were completed and were reviewed by the provider but did not have the provider's score documented. The researchers re-graded the 93 SAGEs and documented scoring discrepancies between the 2 offices. The included results represent the total score difference between the research office and the provider. The SAGE is scored from 0-22 with 0 being the lowest score.

ArmMeasureGroupValue (NUMBER)
Control Group 1Scoring-2 score difference22 SAGEs
Control Group 1Scoring-1 score difference25 SAGEs
Control Group 1Scoring-7 score difference1 SAGEs
Control Group 1Scoring-5 score difference1 SAGEs
Control Group 1Scoring-4 score difference7 SAGEs
Control Group 1Scoring-3 score difference13 SAGEs
Control Group 1Scoring0 score difference19 SAGEs
Control Group 1Scoring+1 score difference3 SAGEs
Control Group 1Scoring+3 score difference2 SAGEs

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026