Alzheimer DiseaseCOADSNCT03300180
Caregiver Outcomes of Alzheimer's Disease Screening
A study testing Collaborative Dementia Care Program and Screening Only in people with Alzheimer Disease, run by Indiana University at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Collaborative Dementia Care Program and Screening Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,822 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2018to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Eskenazi Hospital
Indianapolis, Indiana, 46202
IU Health-Primary Care Clinics
Indianapolis, Indiana, 46202
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Collaborative Dementia Care Program, Screening Only
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Dementia Care ProgramBehavioural
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.
Screening OnlyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The patients in this group will receive no AD screening |
| Screening Only | Active comparator | 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. Receives: Other: Screening Only |
| Collaborative Dementia Care Program | Experimental | 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, Receives: Behavioral: Collaborative Dementia Care Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form Health Survey (SF-36)
The SF-36 is a general population instrument that measures health-related quality of life, mental, physical, and social functioning. It includes one multi-item scale that assesses 8 overall health concepts. These concepts are aggregated into a Physical Component Summary and a Mental Component Summary. The eight domains are combined to reach two summary scores for Physical and Mental Health which are standardized to a mean of 50, with a score above 50 representing better than average and below 50 poorer than average function.
Measured: 24 month
Secondary outcomes (4)
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 with higher scores indicating greater depression severity.
Multi-level mixed effects models will be used to examine differences in PHQ-9 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 PHQ-9 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.
Measured: PHQ-9 results for patient & family member at 24 months
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 with higher scores indicating greater anxiety severity.
Multi-level mixed effects models will be used to examine differences in GAD-7 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 GAD-7 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.
Measured: 24 month GAD-7 scores for Family members & Patients
Caregiving 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.
Multi-level mixed effects models will be used to examine differences in Preparedness for Caregiving Scale scores for 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 Preparedness for Care
Measured: 24 month
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).
Measured: 24 month result for Family member
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start15 Oct 2018
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,822 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Nicole R. Fowler, PhD, Indiana University
- Investigators
- Nicole Fowler, PHD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300180
- Sponsor's protocol ID
- 1705649205
- Other IDs
- 5R01AG056325-05
- Acronym
- COADS
- Status last verified
- Apr 2025
- First submitted
- 8 Aug 2017
- Last updated
- 2 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fowler NR, Perkins AJ, Gao S, Bakas T, Head KJ, Higbie A, Baucco C, Callahan CM, Williams-Farrelly MM, Boustani MA. Benefits and Harms of Dementia Screening for Family Members of Older Adults: A Randomized Clinical Trial. JAMA Intern Med. 2026 Jun 1;186(6):689-700. doi: 10.1001/jamainternmed.2026.0844.
PubMed 42008257Fowler NR, Head KJ, Perkins AJ, Gao S, Callahan CM, Bakas T, Suarez SD, Boustani MA. Examining the benefits and harms of Alzheimer's disease screening for family members of older adults: study protocol for a randomized controlled trial. Trials. 2020 Feb 19;21(1):202. doi: 10.1186/s13063-019-4029-5.
PubMed 32075686
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Outcomes of Alzheimer's Disease Screening
- ClinicalTrials.gov ID
- NCT03300180
- Acronym / sponsor ID
- COADS / 1705649205
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,822 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Posted 2 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The patients in this group will receive no AD screening |
| Screening Only | Active comparator | Other: Screening OnlyThe 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. |
| Collaborative Dementia Care Program | Experimental | Behavioral: Collaborative Dementia Care ProgramThe 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, |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative Dementia Care ProgramMuch 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. | Behavioural | Collaborative Dementia Care Program |
| Screening OnlyThe 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 |
Primary outcome
Short Form Health Survey (SF-36)
Time frame: 24 month
The SF-36 is a general population instrument that measures health-related quality of life, mental, physical, and social functioning. It includes one multi-item scale that assesses 8 overall health concepts. These concepts are aggregated into a Physical Component Summary and a Mental Component Summary. The eight domains are combined to reach two summary scores for Physical and Mental Health which are standardized to a mean of 50, with a score above 50 representing better than average and below 50 poorer than average function.
4 secondary outcomes
Depressive Symptoms
Time frame: PHQ-9 results for patient & family member at 24 months
Anxiety Symptoms
Time frame: 24 month GAD-7 scores for Family members & Patients
Caregiving Preparedness
Time frame: 24 month
Caregiving Self Efficacy
Time frame: 24 month result for Family member
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42008257Fowler NR, Perkins AJ, Gao S, Bakas T, Head KJ, Higbie A, Baucco C, Callahan CM, Williams-Farrelly MM, Boustani MA. Benefits and Harms of Dementia Screening for Family Members of Older Adults: A Randomized Clinical Trial. JAMA Intern Med. 2026 Jun 1;186(6):689-700. doi: 10.1001/jamainternmed.2026.0844.
- Derived from this study: PubMed 32075686Fowler NR, Head KJ, Perkins AJ, Gao S, Callahan CM, Bakas T, Suarez SD, Boustani MA. Examining the benefits and harms of Alzheimer's disease screening for family members of older adults: study protocol for a randomized controlled trial. Trials. 2020 Feb 19;21(1):202. doi: 10.1186/s13063-019-4029-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Fowler, PHD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Dementia Care Program and Screening Only in people with Alzheimer Disease, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form Health Survey (SF-36) (time frame: 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03300180, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.