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DementiaNCT03144921

EPIC: An Intervention for Early-stage AD Dyads - Adapted for Virtual Delivery

A study testing psychoeducational skills training intervention in people with Dementia and Alzheimer Disease, run by Arizona State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

EPIC II (Early-Stage Partners in Care) is a research project designed to assist people with early-stage memory loss and their care partners by providing early-stage related education and skill-training sessions, held via Zoom, designed to reduce stress, enhance well-being, manage challenges, and plan for the future. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dementia, Alzheimer Disease, Memory Loss
What is being tested?
psychoeducational skills training intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
272 participants
Where
1 siteUnited States
Study dates
12 Dec 2017to 30 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

DYAD INCLUSION CRITERIA:

  1. All participants - Care Partners (CP) and Early-Stage People (EP) - will be at least 18 years of age and speak, read, and write English or Spanish.
  2. Eligible dyad relationships include spouse, adult-child relationships (e.g., daughters), and other close friends and family members.
  3. Care partners must self-identify as the person who currently has or who expects to have the most hands-on responsibility and ongoing involvement with the EP.
  4. CPs must live with or have regular contact with the EP.
  5. EPs and CPs must reside in a community setting.

EP INCLUSION CRITERIA:

  1. Live at home rather than an institutional setting,
  2. Have a confirmed diagnosis of OR symptoms consistent with early-stage dementia
  3. Exhibit changes in memory as specified on the AD8 dementia screening tool.
  4. Have a Mini-Mental State Exam (MMSE)i score within a protocol-specified range.
  5. Have a CP who is defined by the EP as being the unpaid "family member" who has or will have primary responsibility for providing assistance to the EP

EP EXCLUSION CRITERIA:

  1. Denying or not reporting any trouble with memory, based on self-report
  2. Normal cognition, based on score derived from screening tool
  3. If yes to BOTH:
  4. severe mental illness or developmental disability before the age of 45
  5. memory problems due to past head injury

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Nationwide Program Locations (Based at ASU Edson College of Nursing and Health Innovation)

    Phoenix, Arizona, 85004

Other trials in United States

About this study

Official title: EPIC: A Group-based Intervention for Early-stage AD Dyads in Diverse Communities

EPIC II (Early-Stage Partners in Care) is a research project designed to assist people with early-stage memory loss and their care partners by providing early-stage related education and skill-training sessions, held via Zoom, designed to reduce stress, enhance well-being, manage challenges, and plan for the future. Researchers will gather feedback from individuals about their experience to continue to improve programs for early-stage memory loss.

Read the detailed description

The purpose of this study is to help early-stage individuals who have early-stage memory loss or early stage dementia and their current or future care partners by providing education and skill-training programs, held via Zoom, designed to reduce stress and distress, increase well-being and quality of life, and plan for the future. About 160 early-stage dyads (person with early-stage dementia and his/her care partner) will be enrolled across the United States through Arizona State University.

People who decide to voluntarily participate in this program, will be asked to:

  • Meet others with memory loss and their care partners.
  • Attend six group sessions via Zoom (2 hours \& 30 minutes each) to learn strategies to help handle new situations, reduce stress, improve mood, communicate better with each other, and plan for the future.
  • Participate in one 90-minute individualized session via Zoom to address specific issues that may be unique to each dyad's situation.
  • Participate in three 2-hour confidential interviews that involve questions about background, mood, and quality of life.
  • Participate in interviews at the start, and again about 3 and 6 months, via Zoom, to help us to continue to improve the program.
  • Attend several monthly booster sessions after completion of the seven EPIC sessions.

Each person will receive up to $45 for completing all follow-up interviews, or $20- 25 for each interview completed. All participants are offered the EPIC sessions shortly after their first interview or shortly after their 3-month interview. Some participants will also attend an additional free education workshop within one month of the initial assessment.

Being tested
psychoeducational skills training intervention
Keywords
Early-stage Dementia, Early-stage Alzheimer's disease, Care partner, Caregivers, Caregiving
Medical subject headings
Dementia, Alzheimer Disease, Memory Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • psychoeducational skills training interventionBehavioural

    This protocol is a minimal risk care values clarification /care planning and psychoeducational skills training intervention, delivered as a workshop series plus one in-home session for people in the early stages of memory loss and their care partner together.

Study groups in NCT03144921
Study groupRoleWhat they receive
EPIC AExperimentalGroup A will start the EPIC intervention immediately after assessment 1. The EPIC program consists of a 7-session, psychoeducational skills training intervention, held via Zoom, designed to provide education and skills on how to prepare for the future and reduce stress regarding memory changes and loss for both the person with early-stage dementia and their care partner. Following the 7 EPIC sessions, participants will attend monthly booster sessions, held via Zoom, to reinforce the skills/lessons. Participants may voluntarily choose to continue attending booster sessions through 2024.
Receives: Behavioral: psychoeducational skills training intervention
EPIC B (WLC)Active comparatorGroup B - the wait list comparison (WLC) group - will have a 75-minute group education session (comparator intervention), held via Zoom, about 3 weeks after baseline assessment. The WLC session is an overview of memory loss/dementia and its related impact for EPs and CPs and an overview of aging network services in the community. They will receive a brief telephone check-in call approximately 3 weeks before the T2 assessment. The WLC group will start the complete EPIC psychoeducational skills training intervention, held via Zoom, immediately after Assessment 2. Following completion of the 7 EPIC sessions, participants will attend monthly booster sessions, held via Zoom, to reinforce the skills/lessons. Participants may voluntarily choose to continue attending booster sessions through 2024.
Receives: Behavioral: psychoeducational skills training intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EP and CP Emotional well-being

    Examine the efficacy of the EPIC intervention as compared with a Wait List Comparison condition by looking at the change over time in the Positive and Negative Affect Scales (Dementia Quality of Life Instrument).

    Measured: Assessments T1-T3 to be conducted over span of six months

  2. EP Quality of Life

    Assess EP Quality of life and CPs perception of EPs Quality of life by looking at the change over time in the Quality of Life Measure in Dementia.

    Measured: Assessments T1-T3 to be conducted over span of six months

Secondary outcomes (3)

  1. Knowledge and Use of Services for People with Dementia and their Care Partners

    Assess the knowledge of, use of, and satisfaction with a variety of services (for example, respite, support groups, case management, referral services) relevant to people with dementia and their care partners by looking at the change over time.

    Measured: Assessments T1-T3 to be conducted over span of six months

  2. Communication Skills and Support within the Dyad

    Assess communication by looking at the change over time in the Dyadic Relationship Scale and Emotional Intimacy Disruptive Behavior Scale.

    Measured: Assessments T1-T3 to be conducted over span of six months

  3. EP and CP Care preparedness

    Assess EP and CP perceptions of how well prepared they feel for addressing future care needs by looking at the change over time in the Care Partners Preparedness Scale (modified).

    Measured: Assessments T1-T3 to be conducted over span of six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2017
  2. Study start12 Dec 2017
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Dyads will be randomized (assigned by chance) to one of two groups: 10 EPIC A or 2) EPIC B (Wait List Control - WLC. Randomization with stratification by language preference (English vs. Spanish) and geographic setting will occur in sets of 4 to 8 (average 6) eligible dyads. The RCT ends at T2 with comparison of changes in outcomes between EPIC and WLC participants from Assessment 1 (baseline) to Assessment 2 (3 months post baseline). T2-T3 assessments will be used for within-group and maintenance of gains analyses from about 3 months to 6 months post baseline.
Masking
None (open label)
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03144921
Sponsor's protocol ID
STUDY00005510, STUDY00012907
Status last verified
Aug 2024
First submitted
2 May 2017
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing psychoeducational skills training intervention in people with Dementia and Alzheimer Disease, run by Arizona State University at 1 site 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?

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 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

EP and CP Emotional well-being (time frame: Assessments T1-T3 to be conducted over span of six months). The study lists 2 primary outcomes in all. 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 NCT03144921.

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 6 Aug 2024.

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Clinical Trial NCT03144921 | AzTrials