Caregiver Outcomes of Alzheimer's Disease Screening

Alzheimer Disease Clinical Trial

— COADS  

Official title:

Caregiver Outcomes of Alzheimer's Disease Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300180
• Other study ID #: 1705649205
• Secondary ID: 5R01AG056325-05
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3734
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

Patients

• 65 years or older

• At least one visit to primary care practice within past 24 months

• 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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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.

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

Locations

Country	Name	City	State
United States	Eskenazi Hospital	Indianapolis	Indiana
United States	IU Health-Primary Care Clinics	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Form Health Survey (SF-36)	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.	24 month
Secondary	Depressive symptoms	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.	24 month
Secondary	Anxiety symptoms	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.	24 month
Secondary	Caregiving preparedness	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.	24 month
Secondary	Caregiving self efficacy	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).	24 month