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Trial record 25 of 461 for:    Recruiting, Not yet recruiting, Available Studies | "Alzheimer Disease"

Caregiver Outcomes of Alzheimer's Disease Screening (COADS)

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ClinicalTrials.gov Identifier: NCT03300180
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : October 25, 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

Detailed Description:

We are proposing the first randomized controlled trial (RCT) to evaluate the benefits and harms of AD screening on family members of older adults. The proposed trial will randomize 1,800 dyads (older adult and family member) into three groups. Older adults in the first group will be screened for AD at baseline coupled with disclosure of the screening results to the dyad and to the patient's primary care provider (Screening Only Group). Older adults in the second group will be screened for AD at baseline coupled with disclosure of the screening results and, if they screen positive, referred to the Aging Brain Care (ABC) Program for diagnostic evaluation and care, if AD is diagnosed (Screening Plus Group). Older adults in the third group will not be screened at baseline and will observed through surveillance of the patients' EHR for any screening or incident AD diagnoses that occurs as part of routine care. At the last follow-up assessment (24 months) we will we will screen the older adults and conduct an interview with the family caregiver to detect possible cognitive impairment (Control Group).

Specific Aim 1: Evaluate the impact of AD screening on family members' quality of life.

Hypothesis 1: In comparison to the control group, family members randomized to the screening only or the screening plus groups will express higher levels of health-related quality of life at 24 months as measured by the Short Form Health Survey (SF-36).

Specific Aim 2: Evaluate the impact of AD screening on family members' mood and anxiety.

Hypothesis 2: In comparison to the control group, family members randomized to the screening only or the screening plus groups will express lower rates of depressive and anxiety symptoms at 24 months as measured by the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder Scale (GAD-7).

Specific Aim 3: Assess the impact of AD screening on family members' caregiving preparedness and caregiving self-efficacy.

Hypothesis 3: In comparison to the control group, family members randomized to the screening only or the screening plus group, will be more prepared for caregiving and have higher self-efficacy at 24 months as measured by the Preparedness for Caregiving Scale and the Revised Scale for Caregiving Self-Efficacy.

Specific Aim 4: Compare the effectiveness of two strategies for diagnostic evaluation and management after AD screening.

Hypothesis 4: In comparison to the screening only group, family members randomized to the screening plus group will express higher levels of health-related quality of life, caregiver preparedness and caregiving self-efficacy and lower levels of depressive and anxiety symptoms at 24 months, as measured by the SF-36, Preparedness for Caregiving Scale, the Revised Scale for Caregiving Self-Efficacy, PHQ-9, and GAD-7, respectively.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Caregiver Outcomes of Alzheimer's Disease Screening
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : September 30, 2023


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. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic and some information about local clinical resources for them to peruse regarding follow-up care. The patient's PCP is also be notified of the screening results via EHR message.
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, Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic. Also, the family member will receive two follow-up phone calls. One from the COADS Study Coordinator and one from a care coordinator at the Aging Brain Care Program (ABC). This phone call will include an opportunity for the family to ask questions and a conversation about the program and diagnostic evaluation and management. Dyads have the option to refuse the follow-up visit. The patient's PCP is also be notified of the screening results via EHR message,
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. Short Form Health Survey (SF-36) [ Time Frame: 24 month ]
    Multi-level mixed effects models will be used to examine differences in SF-36 scores for both patients and family members using dyadic analytic approaches. For this aim, we will compare family members in the two screening groups (Screening Only and Screening Plus) to those in the no screening (Control) group. Repeated SF-36 scores from both patients and family members will be included as the outcome variables with participant type (patient or family member), group (Screening Only and Screening Plus versus Control), time, and interaction between groups and time as independent variables.


Secondary Outcome Measures :
  1. Depressive symptoms [ Time Frame: 24 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.

  2. Anxiety symptoms [ Time Frame: 24 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.

  3. Caregiving preparedness [ Time Frame: 24 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.

  4. Caregiving self efficacy [ Time Frame: 24 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

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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
  • 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
  • Already seen by the Healthy Aging Brain Care Program

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: Shelley Suarez, MSN, RN 317-274-9509 sdsuarez@regenstrief.org

Locations
United States, Indiana
Eskenazi Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Malaz Boustani, MD    317-274-9235    mboustan@iupui.edu   
Principal Investigator: Malaz Boustani, MD         
IU Health-Primary Care Clinics Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lev Inger    317-274-9123    levinger@iupui.edu   
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: October 25, 2018
Last Verified: October 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