Life Enhancing Activities for Family Caregivers (LEAF 2.0)

Not Applicable

Completed

• Conditions: Caregivers
• Interventions: Behavioral: LEAF Positive Emotion Intervention; Other: Emotion Reporting Control Condition

• Registration Number: NCT03610698
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-01
• Study Start: 2020-07-13
• Primary Completion: 2024-09-04
• Study Completion: 2024-09-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 386

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Facilitated Intervention	LEAF Positive Emotion Intervention	Intervention arm facilitated by a trained team member, delivering the 8 positive emotion skills over 5 weeks.
Self-Guided Intervention	LEAF Positive Emotion Intervention	Intervention arm that is self-guided on an online platform, delivering the 8 positive emotion skills over 5 weeks.
Emotion Reporting Control	Emotion Reporting Control Condition	Participants in the emotion reporting control condition will be reporting their emotions daily for the same length as the intervention.

Primary Outcome Measures

Name	Time	Method
Positive Emotion assessed using PROMIS SF v1.0 Positive Affect 15a	Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.	Assess momentary positive or rewarding affective experiences, such as feelings and mood associated with pleasure, joy, elation, contentment, pride, affection, happiness, engagement, and excitement, over the past 7 days, using a scale of not at all to very much, where higher scores indicate higher levels of positive emotion.
Positive and Negative Events assessed using Daily Inventory of Stressful Events (DISE) and Positive Events	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.	An end-of-day measure consisting of a brief set of stem and conditional questions in which participants report whether any of a series of stressful or positive events have occurred within the past 24 hours. Values on the negative events subscale range from "Not at all stressful" to "Very stressful," with a "Didn't happen" option, where higher scores indicate higher levels of stress. Values on the positive events subscale range from "Not at all positive" to "Very positive" with a "Didn't happen" option, where higher scores indicate higher occurrence of positive events and emotions.
Anxiety assessed using PROMIS SF v1.0 Anxiety 8a	Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months..	Assesses depressive mood by having participants rate items focused on depressive symptoms over the past 7 days, using scale from Never to Always, where higher scores indicate higher levels of anxiety.
Positive and Negative Emotions assessed using Modified Differential Emotions Scale: Daily Emotion Check-in (DES).	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.	Used to assess positive and negative emotion experienced within the last 24 hours with scale values ranging from "Never" to "Most of the time," modified to include additional positive affect and positive affectivity items, scored to create total positive and total negative affect scores. A higher score on the positive affect subscale indicates higher levels of positive emotions. A higher scale on the Negative Emotions subscale indicates higher levels of negative emotions.
Perceived Stress using Perceived Stress Scale (PSS-4)	Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.	Used to measure how overloaded, unpredictable, and uncontrollable respondents perceive their lives to be. Scores range from 0 to 40, and higher scores indicate a higher stress level.
Depression assessed using PROMIS SF v1.0 Depression 8a	Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.	Assesses depressive mood by having participants rate items focused on depressive symptoms over the past 7 days, using scale from Never to Always, where higher scores indicate higher levels of depression.

Secondary Outcome Measures

Name	Time	Method
Positive Aspects of Caregiving measured using the Positive Aspects of Caregiving scale	Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.	11-item scale that identifies positive consequences of caregiving, such as feeling more useful, feeling appreciated, and strengthening relationships with others. Values range from "Disagree a lot" to "Agree a lot." Higher scores indicate greater identification of the positives of being a caregiver.
Caregiver self-efficacy/mastery measured using the Caregiving Mastery subscale of the Caregiving Appraisal Measure	Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.	12-item Caregiving Mastery subscale of the Caregiving Appraisal Measure. Values range from "Disagree a lot" to "Agree a lot" and "Never" to "Nearly Always" with higher scores indicating higher feelings of caregiving mastery.
Caregiver Burden measured using the Zarit Burden Interview.	Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.	Assesses perceived burden in caregivers by assessing subjective feelings of the impact of caregiving on emotional and physical health, financial strain, and social functioning. Scale values range from "Never" to "Nearly Always" with higher scores reflect greater burden.
Quality of Care measured using the Satisfaction of One's Own Performance as a Caregiver subscale of the Sense of Competence Questionnaire.	Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.	12-item subscale that measures the caregiver's self-evaluations of their caregiving effectiveness, such as how useful they feel in their interactions with the patient and their capability in caring for the patient. Values range from "No! (Disagree very strongly)" to "Yes! (Agree very strongly)." Higher scores indicate higher satisfaction with performance as a caregiver.
Alzheimer's disease patient quality of life measured using the Quality of Life in Alzheimer's Disease Scale.	Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.	13-item scale, completed by the caregiver regarding the individual living with AD's QOL, assesses several domains on a scale from 1 (poor) to 4 (excellent): physical health, energy, mood, living situation, memory, family, marriage, friends, self, ability to do chores, ability to do things for fun, money, and life as a whole. Scores on the QOL-AD show reasonable correlations with activities of daily living and patient depression.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States