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Completed

NCT Number: NCT01699503

Indiana University Dementia Screening Trial

The purpose of the study is to conduct a randomized clinical trial assessing the harms and benefits of screening for dementia, compared to no screening for dementia, among 4,000 older adults, cared for in typical, primary care practices.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IU Health-Primary Care Clinics, Indianapolis, Indiana, United States

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About this study

The objective of this proposal is to address the question of whether the benefits outweigh the harms of routine screening for dementia among older adults in primary care when the screening program is coupled with primary care practices prepared to provide care for those who screen positive.

The specific aim of the study is to conduct a pragmatic randomized clinical trial assessing the harms and benefits of screening for dementia, compared to no screening for dementia, among 4,000 typical, older adults, cared for in typical, primary care practices, prepared to deliver best practices dementia care.

Primary Specific Aim 1:

Test the impact of dementia screening on health-related quality of life of the patient at 12 months.

Primary Specific Aim 2:

Test the impact of dementia screening on the mood and anxiety symptoms of patient at 1 month (i.e., primary potential harms).

Secondary Aims: Estimate the cost effectiveness of dementia screening.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults age 65 and older;
  • at least one office visit to their primary care physician within the previous year;
  • no previous diagnosis of dementia or memory problem as determined by ICD-9 codes or the presence of prescription for anti-dementia medications (cholinesterase inhibitors or memantine);
  • ability to consent to participate in the study; and
  • ability to communicate in English

Exclusion criteria

  • adults who are a permanent resident of a nursing facility;
  • a serious mental illness such as bipolar disorder or schizophrenia as determined by the presence of related ICD-9 codes indicative of such an illness; or
  • a pre-existing diagnosis of dementia or cognitive impairment

Treatment and study plan

Collaborative Dementia Care Program

Behavioral

Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.

Primary outcomes

  1. Health Related Quality of Life (HRQOL)

    Time frame: 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.

  2. Patient Health Questionnaire (PHQ-9)

    Time frame: 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.

  3. Generalized Anxiety Disorder Scale (GAD-7)

    Time frame: 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 outcomes

  1. Number of Participants With Health Care Utilization

    Time frame: 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.

  2. Number of Participants With an Advance Directive at 12 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)

Registry information

Official study title

Indiana University Dementia Screening Trial: The IU CHOICE Study

Acronym: IU-CHOICE

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 3, 2012
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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