Life Enhancing Activities for Family Caregivers (LEAF 2.0)

Caregivers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03610698
• Other study ID #: SP0044459
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 18, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregivers

Intervention

Behavioral:
• LEAF Positive Emotion Intervention
5-week online intervention teaching 8 positive emotions skills for caregivers

Other:
• Emotion Reporting Control Condition
Daily reporting of emotions for participants assigned to the control condition.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Meaning and Purpose as part of Psychological Well-Being, measured using PROMIS SFv1.0--Meaning and Purpose 8a	Assesses the degree to which one feels life has purpose and there are good reasons for living, including hopefulness, optimism, goal-directedness, and feelings that one's life is worthy. Scale values range from "Strongly disagree" to "Strongly agree" on items 1-3, and "Not at all" to "Very much" on items 4-8, with higher values associated with a higher sense of meaning and purpose.	Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.
Other	Sleep Disturbance as part of Psychological Well-Being, measured by PROMIS SF v1.0--Sleep Disturbance 8b	Measures self-reported perceptions of sleep quality, depth, and restoration within the past 7 days, including difficulty falling asleep and staying asleep and sleep satisfaction. Values range from "Not at all" to "very much" on items 1-4, "Never" to "Always" on items 5-7, and "Very poor" to "Very good" on item 8. Higher scores indicate higher levels of sleep disturbance.	Measures will be taken at baseline, 3 months, 5 months, 7 months, 9 months, 11 months, and 13 months.
Primary	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.
Primary	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.
Primary	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.
Primary	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..
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.