Trial · NCT01699503
Indiana University Dementia Screening Trial
NCT01699503, Not applicable, Completed, Indiana University; results first posted 2019-01-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Indiana University Dementia Screening Trial. Trials, record NCT01699503. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01699503
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Indiana University Dementia Screening Trial
- NCT number
- NCT01699503
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 4,005 participants, actual
- Lead sponsor
- Indiana University
- Conditions
- Dementia, Alzheimer's Disease, Mild Cognitive Impairment
- Interventions
- Collaborative Dementia Care Program
- First posted
- 2012-10-03
- Last updated
- 2019-01-23
- Results first posted
- 2019-01-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Health Related Quality of Life (HRQOL) | 1 month, 6 months, 12 months | The primary outcome measure will be the HRQOL measured at baseline, 1, 6 and 12 months among the entire 4,000 enrollees. The study will use the 15-item Health Utility Index (HUI) to determine the subject's HRQOL. The HUI is a generic, utility-based HRQOL instrument applied in patients with a wide range of medical conditions. It has eight attributes: Vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. The individual health domain scores range from 0.00 (maximum impairment) to 1.00 (no impairment) and the multi-attribute (HUI index) scores, a multiplicative function of individual attribute levels, range from 0.36 to 1.00 with anchors 0.00 = dead and 1.00 = perfect health. |
| Primary | Patient Health Questionnaire (PHQ-9) | 1 month, 6 months, 12 months | The PHQ-9 is a nine-item depression scale with a total score from 0 to 27. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of major depression. A higher score is associated with more severe depression. |
| Primary | Generalized Anxiety Disorder Scale (GAD-7) | 1 month, 6 months, 12 months | The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of general anxiety disorder. A higher score is associated with more severe anxiety. |
| Secondary | Number of Participants With Health Care Utilization | 12 months | The study team will obtain consent at enrollment from all subjects for permission to review their medical records. The Indiana Network for Patient Care (a fully operational Health Information Exchange) will also be used to identify any episode of ambulatory or acute care that occurred within the following 12 months of enrollment date. |
| Secondary | Number of Participants With an Advance Directive at 12 Months | 12 months | The study team will measure the subjects' advanced care planning including having power attorney for health care and/or financial affairs, having a living will, and having life and additional insurance policies at 12 months. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Health Related Quality of Life (HRQOL) | 1 month, 6 months, 12 months | The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study. | units on a scale | MEAN |
| PRIMARY | Patient Health Questionnaire (PHQ-9) | 1 month, 6 months, 12 months | The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study. | units on a scale | MEAN |
| PRIMARY | Generalized Anxiety Disorder Scale (GAD-7) | 1 month, 6 months, 12 months | The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Health Care Utilization | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With an Advance Directive at 12 Months | 12 months | The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Health Related Quality of Life (HRQOL) | Screening Group | 1 Month | 0.71 | Standard Deviation 0.24 | units on a scale |
| Health Related Quality of Life (HRQOL) | No Screening | 1 Month | 0.69 | Standard Deviation 0.26 | units on a scale |
| Health Related Quality of Life (HRQOL) | Screening Group | 6 Month | 0.69 | Standard Deviation 0.26 | units on a scale |
| Health Related Quality of Life (HRQOL) | No Screening | 6 Month | 0.70 | Standard Deviation 0.25 | units on a scale |
| Health Related Quality of Life (HRQOL) | Screening Group | 12 Month | 0.67 | Standard Deviation 0.27 | units on a scale |
| Health Related Quality of Life (HRQOL) | No Screening | 12 Month | 0.68 | Standard Deviation 0.26 | units on a scale |
| Patient Health Questionnaire (PHQ-9) | Screening Group | 1 Month | 2.33 | Standard Deviation 3.22 | units on a scale |
| Patient Health Questionnaire (PHQ-9) | No Screening | 1 Month | 2.46 | Standard Deviation 3.27 | units on a scale |
| Patient Health Questionnaire (PHQ-9) | Screening Group | 6 Month | 2.50 | Standard Deviation 3.43 | units on a scale |
| Patient Health Questionnaire (PHQ-9) | No Screening | 6 Month | 2.45 | Standard Deviation 3.34 | units on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Screening Group | 2,008 | |
| Overall Study | STARTED | No Screening | 1,997 | |
| Overall Study | Baseline | Screening Group | 1,723 | |
| Overall Study | Baseline | No Screening | 1,693 | |
| Overall Study | 1 Month Follow-up | Screening Group | 998 | |
| Overall Study | 1 Month Follow-up | No Screening | 1,022 | |
| Overall Study | 6 Month Follow-up | Screening Group | 903 | |
| Overall Study | 6 Month Follow-up | No Screening | 893 | |
| Overall Study | COMPLETED | Screening Group | 1,008 | |
| Overall Study | COMPLETED | No Screening | 992 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Incident Severe Depression ( | Psychiatric disorders | Screening Group | 34 | 1,723 | |
| serious | Incident Severe Depression ( | Psychiatric disorders | No Screening | 28 | 1,693 | |
| serious | Incident Severe Anxiety | Psychiatric disorders | Screening Group | 18 | 1,723 | |
| serious | Incident Severe Anxiety | Psychiatric disorders | No Screening | 19 | 1,693 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Screening Group | 21 | 1,723 |
| Total, all-cause mortality | No Screening | 25 | 1,693 |
| Total, other adverse events | Screening Group | 0 | 1,723 |
| Total, other adverse events | No Screening | 0 | 1,693 |
| Total, serious adverse events | Screening Group | 52 | 1,723 |
| Total, serious adverse events | No Screening | 47 | 1,693 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AG040220 | Indiana University Dementia Screening Trial: The IU CHOICE Study | BOUSTANI, MALAZ | INDIANA UNIVERSITY INDIANAPOLIS | NATIONAL INSTITUTE ON AGING | 2012 to 2016 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Screening Group vs No Screening: Number of Participants With an Advance Directive at 12 Months | Trial comparisons |
| Screening Group vs No Screening: deaths from any cause | Trial comparisons |
| Screening Group vs No Screening: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01699503
GET https://conductscience.org/api/trials/v1/NCT01699503/results?page=2