ClinicalTrials.gov
ClinicalTrials.gov Menu

Caregiver Outcomes of Alzheimer's Disease Screening (COADS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03300180
Recruitment Status : Not yet recruiting
First Posted : October 3, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Nicole R. Fowler, PhD, Indiana University

Brief Summary:
This study will measure the risks and benefits of early screening of Alzheimer's disease. Early diagnosis through screening may enhance the family member's transition to a family caregiver and reduce caregiver burden by providing an opportunity for the family member to learn about the syndrome, receive interventions, and to prepare for their new care giving role.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Behavioral: Collaborative Dementia Care Program Other: Screening Only Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Caregiver Outcomes of Alzheimer's Disease Screening
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2024


Arm Intervention/treatment
No Intervention: Control
The patients in this group will receive no AD screening
Active Comparator: Screening Only
The patients in this group will receive screening for AD coupled with letters sent to the dyads and the primary care PCP informing them of the results of the screening
Other: Screening Only
The patients in this group will receive screening for AD coupled with letters sent to the dyads and the primary care PCP informing them of the results of the screening

Experimental: Collaborative Dementia Care Program
The patients in this group will receive screening for AD, disclosure letters to the dyads, and the dyads in this group will be referred the Aging Brain Care Medical Home for diagnostic assessment and management if the patient screens positive
Behavioral: Collaborative Dementia Care Program
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 Outcome Measures :
  1. Health Utility Index [ Time Frame: 12 month ]
    The investigators will use the 15-item Health Utility Index (HUI) to determine the caregivers and patients health-related quality of life at each time point. . The individual health domain scores range from 0.00 (maximum impairment) to 1.00 (no impairment); 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.


Secondary Outcome Measures :
  1. Depressive symptoms [ Time Frame: Baseline ]
    The investigators will use the Patient Health Questionnaire-9 (PHQ-9) to determine the impact of AD screening on caregivers and patients mood. The PHQ-9 is a nine-item depression scale with a total score from 0 to 27.

  2. Depressive symptoms [ Time Frame: 6 month ]
    The investigators will use the Patient Health Questionnaire-9 (PHQ-9) to determine the impact of AD screening on caregivers and patients mood. The PHQ-9 is a nine-item depression scale with a total score from 0 to 27.

  3. Depressive symptoms [ Time Frame: 12 month ]
    The investigators will use the Patient Health Questionnaire-9 (PHQ-9) to determine the impact of AD screening on caregivers and patients mood. The PHQ-9 is a nine-item depression scale with a total score from 0 to 27.

  4. Anxiety symptoms [ Time Frame: Baseline ]
    The investigators will use the Generalized Anxiety Disorder Scale (GAD-7) to determine the impact of AD screening on caregivers and patients anxiety. The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21.

  5. Anxiety symptoms [ Time Frame: 6 month ]
    The investigators will use the Generalized Anxiety Disorder Scale (GAD-7) to determine the impact of AD screening on caregivers and patients anxiety. The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21.

  6. Anxiety symptoms [ Time Frame: 12 month ]
    The investigators will use the Generalized Anxiety Disorder Scale (GAD-7) to determine the impact of AD screening on caregivers and patients anxiety. The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21.

  7. Caregiving preparedness [ Time Frame: Baseline ]
    The investigators will use the Preparedness for Caregiving Scale to measure the impact of ADRC screening on family member preparedness. The Preparedness for Caregiving Scale consists of eight items that asks family members how well prepared they believe they are for multiple domains of caregiving. Responses are rated on a 5-point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. The higher the score the more prepared the caregiver feels for caregiving; the lower the score, the less prepared the caregiver feels.

  8. Caregiving preparedness [ Time Frame: 6 month ]
    The investigators will use the Preparedness for Caregiving Scale to measure the impact of ADRC screening on family member preparedness. The Preparedness for Caregiving Scale consists of eight items that asks family members how well prepared they believe they are for multiple domains of caregiving. Responses are rated on a 5-point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. The higher the score the more prepared the caregiver feels for caregiving; the lower the score, the less prepared the caregiver feels.

  9. Caregiving preparedness [ Time Frame: 12 month ]
    The investigators will use the Preparedness for Caregiving Scale to measure the impact of ADRC screening on family member preparedness. The Preparedness for Caregiving Scale consists of eight items that asks family members how well prepared they believe they are for multiple domains of caregiving. Responses are rated on a 5-point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. The higher the score the more prepared the caregiver feels for caregiving; the lower the score, the less prepared the caregiver feels.

  10. Caregiver self efficacy [ Time Frame: Baseline ]
    The investigators will use the Revised Scale for Caregiving Self Efficacy to measure the impact of AD screening on caregiver self-efficacy. Respondents rate their degree of self-efficacy on a scale from 0 (absolutely incapable) to 100 (fully capable).

  11. Caregiving self efficacy [ Time Frame: 6 month ]
    The investigators will use the Revised Scale for Caregiving Self Efficacy to measure the impact of AD screening on caregiver self-efficacy. Respondents rate their degree of self-efficacy on a scale from 0 (absolutely incapable) to 100 (fully capable).

  12. Caregiving self efficacy [ Time Frame: 12 month ]
    The investigators will use the Revised Scale for Caregiving Self Efficacy to measure the impact of AD screening on caregiver self-efficacy. Respondents rate their degree of self-efficacy on a scale from 0 (absolutely incapable) to 100 (fully capable).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients

  • 65 years or older
  • A participant in the CHOICE trial who did not screen positive in the CHOICE trial and has completed the last study assessment.
  • At least one visit to primary care practice within past year
  • Ability to provide informed consent
  • Ability to communicate in English

Family Members

  • 21 years or older
  • Identified by the patient as the person most likely to provide them care if needed.*
  • Lives with the patient or lives within a 50 mile radius.
  • Ability to provide informed consent.
  • Ability to communicate in English

Exclusion Criteria:

Patients

  • Has a diagnosis of AD as determined by ICD-10 code.
  • Evidence of a prescription for a cholinesterase inhibitors or memantine.
  • Has serious mental illness such as bipolar or schizophrenia as determined by ICD-10 code
  • Permanent resident of a nursing facility

Family Member

  • Is a non-family member who is not a legal Healthcare Power of Attorney
  • Has serious mental illness such as bipolar or schizophrenia as determined by ICD-10 code
  • Has a diagnosis of AD as determined by ICD-10 code.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300180


Contacts
Contact: Lev Inger, MPH 317-274-9123 levinger@iupui.edu
Contact: Amanda Harrawood, BS 317-274-9099 aharrawo@iupui.edu

Locations
United States, Indiana
Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
IU Health-Primary Care Clinics
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Nicole Fowler, PHD Indiana University

Responsible Party: Nicole R. Fowler, PhD, Scientist, Indiana University Center for Aging Research, Indiana University
ClinicalTrials.gov Identifier: NCT03300180     History of Changes
Other Study ID Numbers: 1705649205
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders