Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness

NCT01672294 | Completed Results

• 1 other identifier: IIR 11-347
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

Informal caregivers provide a majority of care for patients during serious illness. Lack of preparation and completion may leave caregivers less capable of caring for a loved one or making crucial decisions influencing care. This study will examine whether a preparation and completion intervention reduces caregiver anxiety, depression, anticipatory grief, and burden and improves patient quality of life and health care use.

Conditions

Heart Failure; Pulmonary Disease; Cancer

Keywords

caregiver; end of life; self-disclosure

Outcome Measures

Primary Outcomes (1)

• Caregiver Anxiety

  Profile of Moods States (POMS) anxiety sub-scale The anxiety sub-scale from the modified Brief Profile of Mood States (POMS),7110 a six-item measure of psychological distress. Individual items used a 5 point Likert scale (0-4). The sub-scale minimum score was 0 and maximum was 24 (more anxious ).

  Measured at baseline, 5 weeks, and 8 weeks

Secondary Outcomes (7)

• Spirituality

  Measured at baseline, 5 weeks, and 8 weeks

• Depression

  Measured at baseline, 5 weeks, and 8 weeks

• Patient Days of VA Hospital Use

  In the 6 months after randomization

• Caregiver Burden

  Measured at baseline, 5 weeks, and 8 weeks

• Caregiver Completion

  Measured at baseline, 5 weeks, and 8 weeks

Study Arms (2)

treatment

EXPERIMENTAL

three facilitator-led end-of-life preparation and completion sessions with a facilitator with both patient and caregiver

Other: Preparation and life completion

attention control

ACTIVE COMPARATOR

three facilitator led sessions of listening to a relaxation CD.

Other: Attention Control

Interventions

Preparation and life completion OTHER

Caregiver subjects will discuss life review, issues of forgiveness and heritage and legacy.

treatment

Attention Control OTHER

Caregiver subjects will listen to a non-guided relaxation CD with facilitator.

attention control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with advanced cancer/Congestive heart failure/COPD/End stage renal disease who have a primary caregiver. Caregivers of Durham VAMC patients with advanced disease.

You may not qualify if:

• No caregiver present.
• Caregiver with Cognitive impairment/inability to speak on phone/non-English speaking

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Heart Failure; Lung Diseases; Neoplasms; Death

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Karen Steinhauser, PhD
• Organization: VA HSRD Durham VA Medical Center

karen.steinhauser@va.gov

9196682148

Study Officials

• Karen E Steinhauser, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: August 24, 2012
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: April 17, 2017
• Results First Posted: April 17, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)