Mindfulness and Support Group to Improve Patient and Caregiver Burden in Cirrhosis

NCT02944643 | Completed

• 1 other identifier: BAJAJ0019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic liver disease and cirrhosis pose a huge financial burden to the health care system. This includes the cost of medical care, employment, disability-related issues and reduced survival. Specifically, the complication of cirrhosis known as hepatic encephalopathy (HE) especially hinders quality of life, the performance of activities of daily living and the ability to drive a motor vehicle in affected subjects. The hidden burden to family members and caregivers of these subjects, however, has been all but ignored to date. Evaluation of family members and caregivers is essential. The burden of caring for someone with liver disease can result in added cost for health care for family members and caregivers and is typically not recognized. The importance of the burden to families and family members or caregivers resulting from other neurological diseases such as Alzheimer's has been well evaluated and specific strategies to educate and counsel family members and caregivers have been elaborated. This is important because as the findings of this study have emerged, we have found that both Veterans and non-Veterans with cirrhosis and HE have a poor quality of life, worse socio-economic status and place a significantly higher burden on their family members or caregivers than those without HE

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory (patients)

  4 weeks

Secondary Outcomes (5)

• Beck Anxiety Inventory (patients)

  4 weeks

• Zarit Burden Interview (caregivers only)

  4 weeks

• Sickness Impact Profile (patients)

  4 weeks

• Pittsburgh Sleep Quality Index (patients)

  4 weeks

• Epworth Sleepiness Scale (patients)

  4 weeks

Study Arms (1)

Active group

EXPERIMENTAL

Will get the mindfulness and support groups

Other: Mindfulness and Support Groups

Interventions

Mindfulness and Support Groups OTHER

Active group

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhosis proven by radiology, endoscopy (esophageal varices present) or biopsy
• Able to give informed consent as determined by the study staff
• Have a family member or caregiver who lives with them that is willing to participate

You may not qualify if:

• Unable to give consent
• Active psychosis
• Acute suicidal ideation
• No identified family member or caregiver
• Caregivers/Family members:
• Sharing living space with cirrhotic patient for at least 3 years
• Able and willing to participate in the groups
• Unfamiliar with patient's routines and does not live in the same space
• Unwilling to consent or participate

Sponsors & Collaborators

• Hunter Holmes Mcguire Veteran Affairs Medical Center: lead

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Fibrosis

Interventions

Mindfulness; Self-Help Groups

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Organizations; Health Care Economics and Organizations

Study Officials

• Jasmohan S Bajaj, MD

  Mcguire VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, GI Section

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 26, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 12, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)