Life Enhancing Activities for Family Caregivers

Dementia Clinical Trial

— LEAF  

Official title:

Life Enhancing Activities for Family Caregivers (LEAF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825681
• Other study ID #: 14-13236
• Secondary ID: A115168
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Life Enhancing Activities for Family Caregivers is a six-week program designed to increase positive affect in people who care for a family member with dementia. The intervention consists of 6 weekly one-hour sessions conducted one-on-one with a trained facilitator to teach simple skills that are practiced at home in a study-supplied workbook. The program is preceded and followed by a 30-45 minute questionnaire. Follow-up assessments will be conducted at 1-month, 3-months, and 6-months post intervention.

Primary hypothesis is that experimental subjects who participate in LEAF will demonstrate significantly greater improvements in psychological outcomes and will engage in more problem focused and positive appraisal forms of coping compared to the wait-list control condition.

Description:

All study activities can be conducted from the participant's home, making participation possible for any qualified caregiver with computer and wifi access, in any U.S. state. The LEAF study will supply the tablet computer, software, and workbook required for participation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: June 30, 2019
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must be able to be defined as the primary care provider for a family member with dementia. (Person with dementia must live with the caregiver or in their own home and not in a care facility.)

• Must speak and read English

• Must have the ability to provide informed consent

Exclusion Criteria:

• Lack of access to a high speed internet connection

• Evidence of severe cognitive impairment or active psychosis, as assessed by trained interviewers

Related Conditions & MeSH terms

• Affect
• Dementia
• Stress

Intervention

Behavioral:
• Positive Affect
Six-session skill-building program designed to raise levels of positive emotion when skills are practiced over the duration of the program.

Locations

Country	Name	City	State
United States	UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repeated measures of the modified version of the Differential Emotions Scale (DES) (Izard, 1977)	The DES will be used to assess positive and negative affect. This 20-item version of the DES was modified to include additional positive affect items as well as those that are likely to tap into trait positive affectivity. The full scale assesses interest, enjoyment, surprise, sadness, anger, disgust, contempt, fear, guilt, shame, shyness, amusement, awe, contentment, gratitude, hope, love, pride, sympathy, and sexual feelings (e.g., "I felt sexual, desiring, and flirtatious"). The scale can be scored for total positive and negative affect,grouped according to where they would fall on the circumplex model of affect (e.g., high activation vs. lower activation),or individual affects can be examined. In student samples this modified DES has shown acceptable reliability with the positive affects subscale (a = .79) and the negative affects subscale (a = .69).	Baseline and weeks 6 and 10; 3-months and 6-months post
Secondary	Change in burden at end of intervention, 3 and 6-months post - Zarit Burden Inventory (Zarit, Reever, & Bach-Peterson, 1980)	22-item inventory assesses caregivers' subjective feelings of the impact of caregiving on emotional and physical health functioning, social life, and financial status.	Baseline and weeks 6 and 10; 3-months and 6-months post
Secondary	Change in perceived stress at end of intervention, 3 and 6-months post - Perceived Stress Scale (PSS) (Cohen, 1988)	The 10 items are designed to identify how unpredictable, uncontrollable and overloaded respondents find their lives. Scores range from 0-40, with higher scores indicating greater stress.	Baseline and weeks 6 and 10; 3-months and 6-months post
Secondary	Change in caregiver strain at end of intervention, 3 and 6-months post - Caregiver Strain Index (CSI) (Robinson, 1983)	The CSI is a 13-item measure of both objective and subjective elements of caregiver strain.	Baseline and weeks 6 and 10; 3-months and 6-months post
Secondary	Change in depression at end of intervention, 3 and 6-months post - Depression, Patient Reported Outcomes Measurement Information System Item Bank, v. 1.0 (PROMIS; Cella et al., 2010)	Used to assess depressive mood.	Baseline and weeks 6 and 10; 3-months and 6-months post
Secondary	Change in anxiety at end of intervention, 3 and 6-months post - Emotional Distress - Anxiety, PROMIS Item Bank v. 1.0 (Cella et al., 2010)	Used to assess anxiety.	Baseline and weeks 6 and 10; 3-months and 6-months post
Secondary	Change in coping at end of intervention, 3 and 6-months post - Ways of Coping Scale (Folkman, Lazarus, Pimley, & Novacek, 1987)	The 23 forms of coping responses assessed include: confrontive coping, escape-avoidance, planful problem-solving, positive reappraisal, benefit, growth, mastery of stress, other success, purpose, positive relations with others, religion, and respite, benevolent and negative religious coping, emotional processing and expression, goal replacement, and maintaining optimism.	Baseline and weeks 6 and 10; 3-months and 6-months post