Life Enhancing Activities for Family Caregivers (LEAF 2.0)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Trial of a Technology-based Positive Emotion Intervention for Informal Caregivers of Individuals With Alzheimer's Disease

Conditions
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Caregivers

Intervention / Treatment
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* Behavioral: LEAF Positive Emotion Intervention
* Other: Emotion Reporting Control Condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Facilitated Intervention<br>Intervention arm facilitated by a trained team member, delivering the 8 positive emotion skills over 5 weeks. | Behavioral: LEAF Positive Emotion Intervention<br>* 5-week online intervention teaching 8 positive emotions skills for caregivers<br>|
| Experimental: Self-Guided Intervention<br>Intervention arm that is self-guided on an online platform, delivering the 8 positive emotion skills over 5 weeks. | Behavioral: LEAF Positive Emotion Intervention<br>* 5-week online intervention teaching 8 positive emotions skills for caregivers<br>|
| Active Comparator: Emotion Reporting Control<br>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<br>* Daily reporting of emotions for participants assigned to the control condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Emotion assessed using PROMIS SF v1.0 Positive Affect 15a | 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. | Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months. | 
| Positive and Negative Emotions assessed using Modified Differential Emotions Scale: Daily Emotion Check-in (DES). | 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. | 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. | 
| Positive and Negative Events assessed using Daily Inventory of Stressful Events (DISE) and Positive Events | 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. | 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. | 
| Anxiety assessed using PROMIS SF v1.0 Anxiety 8a | 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. | Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.. | 
| Depression assessed using PROMIS SF v1.0 Depression 8a | 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. | Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months. | 
| Perceived Stress using Perceived Stress Scale (PSS-4) | 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. | Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver Burden measured using the Zarit Burden Interview. | 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. | Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months. | 
| Caregiver self-efficacy/mastery measured using the Caregiving Mastery subscale of the Caregiving Appraisal Measure | 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. | Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months. | 
| Positive Aspects of Caregiving measured using the Positive Aspects of Caregiving scale | 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. | Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months. | 
| Quality of Care measured using the Satisfaction of One's Own Performance as a Caregiver subscale of the Sense of Competence Questionnaire. | 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. | Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months. | 
| Alzheimer's disease patient quality of life measured using the Quality of Life in Alzheimer's Disease Scale. | 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. | Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caregiving, psychological well-being, Alzheimer's disease, positive emotion