Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Life Enhancing Activities for Family Caregivers (LEAF 2.0)

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: NCT03610698
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : July 2, 2020
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Judith Moskowitz, Northwestern University

Brief Summary:
The goal of the proposed intervention, called LEAF (Life Enhancing Activities for Family Caregivers) is to reduce burden and increase well-being in Alzheimer's Disease caregivers through the practice of positive emotion skills. We will evaluate two methods of online delivery of LEAF: facilitated and self-guided and compare them to an emotion-reporting waitlist control condition. If effective, the LEAF program can be disseminated to Alzheimer caregivers nation wide.

Condition or disease Intervention/treatment Phase
Caregivers Behavioral: LEAF Positive Emotion Intervention Other: Emotion Reporting Control Condition Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial of a Technology-based Positive Emotion Intervention for Informal Caregivers of Individuals With Alzheimer's Disease
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Facilitated Intervention
Intervention arm facilitated by a trained team member, delivering the 8 positive emotion skills over 5 weeks.
Behavioral: LEAF Positive Emotion Intervention
5-week online intervention teaching 8 positive emotions skills for caregivers

Experimental: Self-Guided Intervention
Intervention arm that is self-guided on an online platform, delivering the 8 positive emotion skills over 5 weeks.
Behavioral: LEAF Positive Emotion Intervention
5-week online intervention teaching 8 positive emotions skills for caregivers

Active Comparator: Emotion Reporting Control
Participants in the emotion reporting control condition will be reporting their emotions daily for the same length as the intervention.
Other: Emotion Reporting Control Condition
Daily reporting of emotions for participants assigned to the control condition.




Primary Outcome Measures :
  1. Psychological Well-Being [ Time Frame: Measures will be taken at baseline. ]
    Psychological well-being assessed using the NIH Toolbox.

  2. Psychological Well-Being [ Time Frame: Measures will be taken at 3 months. ]
    Psychological well-being assessed using the NIH Toolbox.

  3. Psychological Well-Being [ Time Frame: Measures will be taken at 5 months. ]
    Psychological well-being assessed using the NIH Toolbox.

  4. Psychological Well-Being [ Time Frame: Measures will be taken at 7 months. ]
    Psychological well-being assessed using the NIH Toolbox.

  5. Psychological Well-Being [ Time Frame: Measures will be taken at 9 months. ]
    Psychological well-being assessed using the NIH Toolbox.

  6. Psychological Well-Being [ Time Frame: Measures will be taken at 11 months. ]
    Psychological well-being assessed using the NIH Toolbox.

  7. Psychological Well-Being [ Time Frame: Measures will be taken at 13 months. ]
    Psychological well-being assessed using the NIH Toolbox.

  8. PROMIS-Anxiety [ Time Frame: Measures will be taken at baseline. ]
    We will measure anxiety using the PROMIS short-form.

  9. PROMIS-Anxiety [ Time Frame: Measures will be taken at 3 months. ]
    We will measure anxiety using the PROMIS short-form.

  10. PROMIS-Anxiety [ Time Frame: Measures will be taken at 5 months. ]
    We will measure anxiety using the PROMIS short-form.

  11. PROMIS-Anxiety [ Time Frame: Measures will be taken at 7 months. ]
    We will measure anxiety using the PROMIS short-form.

  12. PROMIS-Anxiety [ Time Frame: Measures will be taken at 9 months. ]
    We will measure anxiety using the PROMIS short-form.

  13. PROMIS-Anxiety [ Time Frame: Measures will be taken at 11 months. ]
    We will measure anxiety using the PROMIS short-form.

  14. PROMIS-Anxiety [ Time Frame: Measures will be taken at 13 months. ]
    We will measure anxiety using the PROMIS short-form.

  15. PROMIS-Depression [ Time Frame: Measures will be taken at baseline. ]
    We will measure depression using the PROMIS short-form.

  16. PROMIS-Depression [ Time Frame: Measures will be taken at 3 months. ]
    We will measure depression using the PROMIS short-form.

  17. PROMIS-Depression [ Time Frame: Measures will be taken at 5 months. ]
    We will measure depression using the PROMIS short-form.

  18. PROMIS-Depression [ Time Frame: Measures will be taken at 7 months. ]
    We will measure depression using the PROMIS short-form.

  19. PROMIS-Depression [ Time Frame: Measures will be taken at 9 months. ]
    We will measure depression using the PROMIS short-form.

  20. PROMIS-Depression [ Time Frame: Measures will be taken at 11 months. ]
    We will measure depression using the PROMIS short-form.

  21. PROMIS-Depression [ Time Frame: Measures will be taken at 13 months. ]
    We will measure depression using the PROMIS short-form.


Secondary Outcome Measures :
  1. Caregiver Burden [ Time Frame: Measures will be taken at baseline. ]
    This will be measured using the Zarit Burden Interview.

  2. Caregiver Burden [ Time Frame: Measures will be taken at 3 months. ]
    This will be measured using the Zarit Burden Interview.

  3. Caregiver Burden [ Time Frame: Measures will be taken at 5 months. ]
    This will be measured using the Zarit Burden Interview.

  4. Caregiver Burden [ Time Frame: Measures will be taken at 7 months. ]
    This will be measured using the Zarit Burden Interview.

  5. Caregiver Burden [ Time Frame: Measures will be taken at 9 months. ]
    This will be measured using the Zarit Burden Interview.

  6. Caregiver Burden [ Time Frame: Measures will be taken at 11 months. ]
    This will be measured using the Zarit Burden Interview.

  7. Caregiver Burden [ Time Frame: Measures will be taken at 13 months. ]
    This will be measured using the Zarit Burden Interview.


Other Outcome Measures:
  1. Caregiver Mastery [ Time Frame: Measures will be taken at baseline. ]
    This will be measured using the Caregiving Mastery subscale of the Caregiving Appraisal Measure.

  2. Caregiver Mastery [ Time Frame: Measures will be taken at 3 months. ]
    This will be measured using the Caregiving Mastery subscale of the Caregiving Appraisal Measure.

  3. Caregiver Mastery [ Time Frame: Measures will be taken at 5 months. ]
    This will be measured using the Caregiving Mastery subscale of the Caregiving Appraisal Measure.

  4. Caregiver Mastery [ Time Frame: Measures will be taken at 7 months. ]
    This will be measured using the Caregiving Mastery subscale of the Caregiving Appraisal Measure.

  5. Caregiver Mastery [ Time Frame: Measures will be taken at 9 months. ]
    This will be measured using the Caregiving Mastery subscale of the Caregiving Appraisal Measure.

  6. Caregiver Mastery [ Time Frame: Measures will be taken at 11 months. ]
    This will be measured using the Caregiving Mastery subscale of the Caregiving Appraisal Measure.

  7. Caregiver Mastery [ Time Frame: Measures will be taken at 13 months. ]
    This will be measured using the Caregiving Mastery subscale of the Caregiving Appraisal Measure.



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.


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

Inclusion Criteria:

  • Adult age 18 and over who identifies as the primary caregiver of a family member with a degenerative dementia condition
  • Co-resides with the family caregiver
  • Speaks and reads English
  • Have access to high speed internet connection at home or a location where they can speak privately with a facilitator

Exclusion Criteria:

-


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): NCT03610698


Contacts
Layout table for location contacts
Contact: Amanda Summers, MA 312-503-7712 amanda.summers@northwestern.edu
Contact: Kari Snowberg, MA Karin.Snowberg@ucsf.edu

Locations
Layout table for location information
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
University of California, San Francisco
Layout table for additonal information
Responsible Party: Judith Moskowitz, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03610698    
Other Study ID Numbers: SP0044459
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Judith Moskowitz, Northwestern University:
caregiving
psychological well-being
alzheimer's
positive emotion