Clinical trial NCT03610698: Life Enhancing Activities for Family Caregivers (LEAF 2.0)
Official title: Randomized Trial of a Technology-based Positive Emotion Intervention for Informal Caregivers of Individuals With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers
Keywords: caregiving
psychological well-being
Alzheimer's disease
positive emotion
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2018-08-01
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: LEAF 2.0 is a 3-arm, technology-based, randomized controlled trial (N = 500) in which family caregivers of patients with Alzheimer's Disease (AD) are randomly assigned to 1) the LEAF intervention facilitated remotely via web (N = 200), 2) the LEAF intervention self-guided online (N = 200), or 3) an emotion reporting control (N = 100) which will then cross over to the intervention after approximately 7 months, half to the facilitated arm and half to the self-guided arm. Participants will complete a program that teaches them eight positive emotion skills which aim to reduce stress and burden, and increase positive affect. All aspects of the study (recruitment, consent, intervention, and assessments) are conducted online.

To be eligible for participation in LEAF 2.0, participants must identify as the primary family caregiver of someone with Alzheimer's disease or Alzheimer's-related dementia, and whose care recipient is not living in a care facility at the time of enrollment. "Primary family caregiver" is defined as the person who spends the most time caring for the individual with Alzheimer's disease in a non-professional capacity. Participants must also be able to speak and read English, live in the United States, be at least 18 years of age, and have access to a reliable Wi-Fi connection. Respondents are ineligible if they have already participated in a prior version of LEAF.

Eligibility criteria: Inclusion Criteria:

* Adult age 18 and over who identifies as the primary caregiver of a family member with Alzheimer's disease or probable Alzheimer's
* Care recipient does NOT reside in care facility
* Speaks and reads English
* Has access to high speed internet connection at home or a location where they can speak privately with a facilitator

Exclusion Criteria:

* Care recipient lives in care facility
* Does not speak/read English
* Does not have access to internet
* Care recipient does not have Alzheimer's disease

Primary outcomes:
measure: Positive Emotion assessed using PROMIS SF v1.0 Positive Affect 15a
timeFrame: Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.
measure: Positive and Negative Emotions assessed using Modified Differential Emotions Scale: Daily Emotion Check-in (DES).
timeFrame: Measures will be taken at baseline, daily during 8 week intervention or control period, at 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.
measure: Positive and Negative Events assessed using Daily Inventory of Stressful Events (DISE) and Positive Events
timeFrame: Measures will be taken at baseline, daily during 8 week intervention or control period, at 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.
measure: Anxiety assessed using PROMIS SF v1.0 Anxiety 8a
timeFrame: Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months..
measure: Depression assessed using PROMIS SF v1.0 Depression 8a
timeFrame: Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.
measure: Perceived Stress using Perceived Stress Scale (PSS-4)
timeFrame: Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.
Secondary outcomes:
measure: Caregiver Burden measured using the Zarit Burden Interview.
timeFrame: Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.
measure: Caregiver self-efficacy/mastery measured using the Caregiving Mastery subscale of the Caregiving Appraisal Measure
timeFrame: Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.
measure: Positive Aspects of Caregiving measured using the Positive Aspects of Caregiving scale
timeFrame: Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.
measure: Quality of Care measured using the Satisfaction of One's Own Performance as a Caregiver subscale of the Sense of Competence Questionnaire.
timeFrame: Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.
measure: Alzheimer's disease patient quality of life measured using the Quality of Life in Alzheimer's Disease Scale.
timeFrame: Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.
Other outcomes:
measure: Meaning and Purpose as part of Psychological Well-Being, measured using PROMIS SFv1.0--Meaning and Purpose 8a
timeFrame: Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.
measure: Sleep Disturbance as part of Psychological Well-Being, measured by PROMIS SF v1.0--Sleep Disturbance 8b
timeFrame: Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Judith Moskowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: