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EPIC: An Intervention for Early-stage AD Dyads

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: NCT03144921
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
David W Coon, Arizona State University

Brief 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 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.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Memory Loss Behavioral: psychoeducational skills training intervention Not Applicable

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 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 Arizona and Nevada 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 (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 to address specific issues that may be unique to each dyad's situation.
  • Participate in five 2-hour confidential interviews that involve questions about background, mood, and quality of life.
  • Participate in interviews at the start, and again about 3, 6, 9 and 12 months, 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 $95 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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-T5 assessments will be used for within-group and maintenance of gains analyses from about 3 months to 12 months post baseline.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EPIC: A Group-based Intervention for Early-stage AD Dyads in Diverse Communities
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia Memory

Arm Intervention/treatment
Experimental: EPIC A
Group A will start the EPIC intervention immediately after assessment 1. The EPIC program consists of a 7-session, psychoeducational skills training intervention 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 up to 12 months to reinforce the skills/lessons.
Behavioral: psychoeducational skills training intervention
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.

Active Comparator: EPIC B (WLC)
Group B - the wait list comparison (WLC) group - will have a 75-minute group education session (comparator intervention) 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 immediately after Assessment 2. Following completion of the 7 EPIC sessions, participants will attend monthly booster sessions up to 12 months to reinforce the skills/lessons.
Behavioral: psychoeducational skills training intervention
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.




Primary Outcome Measures :
  1. EP and CP Emotional well-being [ Time Frame: Assessments T1-T5 to be conducted over span of one year ]
    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).

  2. EP Quality of Life [ Time Frame: Assessments T1-T5 to be conducted over span of one year ]
    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.


Secondary Outcome Measures :
  1. Knowledge and Use of Services for People with Dementia and their Care Partners [ Time Frame: Assessments T1-T5 to be conducted over span of one year ]
    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.

  2. Communication Skills and Support within the Dyad [ Time Frame: Assessments T1-T5 to be conducted over span of one year ]
    Assess communication by looking at the change over time in the Dyadic Relationship Scale and Emotional Intimacy Disruptive Behavior Scale.

  3. EP and CP Care preparedness [ Time Frame: Assessments T1-T5 to be conducted over span of one year ]
    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).


Other Outcome Measures:
  1. Initial incremental cost effectiveness of EPIC compared with Wait List Comparison condition [ Time Frame: T1 - T2 Assessments (Baseline to 3 months) ]
    Based on Quality of Life Adjusted Years for the EPs and hours providing care for CPs, conduct a cost benefit analysis to explicitly indicate whether benefits of the EPIC program outweigh costs by looking at the change over time.



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

    1. severe mental illness or developmental disability before the age of 45
    2. memory problems due to past head injury

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): NCT03144921


Contacts
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Contact: Coon Research Team 602-496-1239 coonresearch@asu.edu
Contact: Marielysse Cortes, MSW 602-496-1281 marielysse.cortes@asu.edu

Locations
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United States, Arizona
Arizona & Nevada Program Locations (Based at ASU Edson College of Nursing and Health Innovation) Recruiting
Phoenix, Arizona, United States, 85004
Contact: Marielysse Cortes, MSW       marielysse.cortes@asu.edu   
Principal Investigator: David W. Coon, PhD         
Sponsors and Collaborators
Arizona State University
Investigators
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Principal Investigator: David W. Coon, PhD Arizona State University

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Responsible Party: David W Coon, Associate Dean, R.I.S.E. and Professor, Arizona State University
ClinicalTrials.gov Identifier: NCT03144921    
Other Study ID Numbers: STUDY00005510
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David W Coon, Arizona State University:
Early-stage Dementia
Early-stage Alzheimer's disease
Care partner
Caregivers
Caregiving
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Memory Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms