Trial Outcomes & Findings for SAGE for the Early Detection of Cognitive Impairment at Primary Care Provider Visits (NCT NCT04063371)
NCT ID: NCT04063371
Last Updated: 2024-05-14
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
300 participants
Primary outcome timeframe
60 days
Results posted on
2024-05-14
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
Control Group 2
Control group 2 consists of patients handled by the intervention office who did not complete the SAGE or eSAGE.
|
|---|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SAGE for the Early Detection of Cognitive Impairment at Primary Care Provider Visits
Baseline characteristics by cohort
| Measure |
Control Group 1
n=100 Participants
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.
|
Intervention Group
n=100 Participants
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.
|
Control Group 2
n=100 Participants
Control group 2 consists of patients handled by the intervention office who did not complete the SAGE or eSAGE.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.0781 years
n=93 Participants
|
71.46759 years
n=4 Participants
|
71.53598 years
n=27 Participants
|
70.88031 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
67 Participants
n=27 Participants
|
182 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
118 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
African American
|
10 participants
n=93 Participants
|
16 participants
n=4 Participants
|
22 participants
n=27 Participants
|
48 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
82 participants
n=93 Participants
|
83 participants
n=4 Participants
|
74 participants
n=27 Participants
|
239 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 participants
n=93 Participants
|
1 participants
n=4 Participants
|
4 participants
n=27 Participants
|
13 participants
n=483 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=93 Participants
|
100 participants
n=4 Participants
|
100 participants
n=27 Participants
|
300 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group 1
n=100 Participants
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.
|
Intervention Group
n=100 Participants
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.
|
Control Group 2
n=100 Participants
Control group 2 consists of patients handled by the intervention office who did not complete the SAGE or eSAGE.
|
|---|---|---|---|
|
Number of Participants With a Diagnosis of a Cognitive Impairment Disorder Measured by Pharmacological Interventions for the Management of Cognitive Impairment.
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 60 daysNumber of participants in the intervention and the two control groups with any referral for further evaluation/management of potential cognitive impairment.
Outcome measures
| Measure |
Control Group 1
n=100 Participants
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.
|
Intervention Group
n=100 Participants
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.
|
Control Group 2
n=100 Participants
Control group 2 consists of patients handled by the intervention office who did not complete the SAGE or eSAGE.
|
|---|---|---|---|
|
Number of Participants in the Intervention and Control Groups With Any Referral for Further Evaluation/Management of Potential Cognitive Impairment
|
2 participants
|
7 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group 1
n=100 Participants
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.
|
Intervention Group
n=100 Participants
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.
|
Control Group 2
n=100 Participants
Control group 2 consists of patients handled by the intervention office who did not complete the SAGE or eSAGE.
|
|---|---|---|---|
|
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 participants
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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.
Number of referrals used for subjects in the intervention and two control groups for further evaluation/management of potential cognitive impairment.
Outcome measures
| Measure |
Control Group 1
n=100 Participants
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.
|
Intervention Group
n=100 Participants
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.
|
Control Group 2
n=100 Participants
Control group 2 consists of patients handled by the intervention office who did not complete the SAGE or eSAGE.
|
|---|---|---|---|
|
Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.
neuropsychological testing
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.
Lab work
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.
Neuroimaging
|
1 participants
|
4 participants
|
0 participants
|
|
Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.
neurology/psychiatry
|
2 participants
|
4 participants
|
0 participants
|
|
Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.
occupational therapy
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.
physical therapy
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.
speech therapy
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.
counseling
|
0 participants
|
3 participants
|
0 participants
|
|
Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.
respite care
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.
legal assistance
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.
day care
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.
home health
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.
social work
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.
financial planning
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.
cognitive research
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.
other
|
1 participants
|
6 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 daysPopulation: 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.
Differences of SAGE and eSAGE scoring between intervention office and research site.
Outcome measures
| Measure |
Control Group 1
n=93 SAGE tests
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.
|
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.
|
Control Group 2
Control group 2 consists of patients handled by the intervention office who did not complete the SAGE or eSAGE.
|
|---|---|---|---|
|
Scoring
-7 score difference
|
1 SAGEs
|
—
|
—
|
|
Scoring
-5 score difference
|
1 SAGEs
|
—
|
—
|
|
Scoring
-4 score difference
|
7 SAGEs
|
—
|
—
|
|
Scoring
-3 score difference
|
13 SAGEs
|
—
|
—
|
|
Scoring
-2 score difference
|
22 SAGEs
|
—
|
—
|
|
Scoring
-1 score difference
|
25 SAGEs
|
—
|
—
|
|
Scoring
0 score difference
|
19 SAGEs
|
—
|
—
|
|
Scoring
+1 score difference
|
3 SAGEs
|
—
|
—
|
|
Scoring
+3 score difference
|
2 SAGEs
|
—
|
—
|
SECONDARY outcome
Timeframe: 60 daysResults of the questionnaire to evaluate the practicality and ease of use of the SAGE and eSAGE test by primary care providers and staff.
Outcome measures
| Measure |
Control Group 1
n=7 Participants
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.
|
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.
|
Control Group 2
Control group 2 consists of patients handled by the intervention office who did not complete the SAGE or eSAGE.
|
|---|---|---|---|
|
Questionnaires
Would recommend the SAGE test during office visits for other colleagues
|
6 Participants
|
—
|
—
|
|
Questionnaires
Would not recommend the SAGE test during office visits for other colleagues
|
1 Participants
|
—
|
—
|
Adverse Events
Control Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place