Caregiver Outlook: An Evidence-based Intervention for the Chaplain Toolkit

NCT01768221 | Completed

• 1 other identifier: Pro00039370
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This one-arm pilot study will evaluate the feasibility and acceptability of Caregiver Outlook, a manualized chaplain-led intervention to improve the well-being of caregivers of seriously ill patients. Study Activities and Population Group: The investigators anticipate enrolling 36 informal caregivers (adults) through DUMC providers and/or self-referral. Potential subjects will be screened for study eligibility, consented if eligible and interested, and one week later administered a baseline survey by phone. Next, the chaplain-led intervention will be delivered by phone in three one-hour sessions, spanning a one month window. After session 3, subjects will receive a check-in phone call to briefly discuss their any additional thoughts, questions or concerns they may have. Sessions will be audio recorded. After intervention completion, follow-up surveys will be administered by phone at two points in time. Data Analysis and Risk/Safety Issues: This is a mixed-methods study involving qualitative thematic analysis and survey data, collected from the adult caregiver subjects. There are no known physical risks to participation, and the study team will work to ensure confidentiality and data safety/integrity.

Conditions

Caregiver Wellbeing

Keywords

Palliative Care; Caregiver Outlook

Outcome Measures

Primary Outcomes (1)

• Feasibility and acceptability of a chaplain-led intervention

  Assess caregivers' spiritual strengths and experiences by conducting surveys and interviews to measure change in anxiety, preparation and completion, grief, depression and caregiver reactions at baseline and post intervention at 6 weeks, and 8 weeks.

  8 weeks

Secondary Outcomes (3)

• Caregiver Outlook intervention qualitative discussion theme content and variation

  Baseline (week 1)

• Intervention responses

  Weeks 2-5

• Evaluate and establish effect sizes associated with Caregiver Outlook on caregiver anxiety, depression, anticipatory grief, quality of life, and burden.

  Baseline (week 1), Followup (Week 6), Followup 2 (Week 8)

Study Arms (1)

Caregiver intervention

OTHER

Behavioral: Caregiver Intervention

Interventions

Caregiver Intervention BEHAVIORAL

Participants will speak with a chaplain for three brief, 45 minute to one hour, sessions. The sessions will focus on topics of relationship life review, unresolved conflicts and issues of forgiveness, and future goals, lessons learned and legacy. In the week following the third session, the chaplain will call participants for a brief check in. This call will include no new intervention content, rather it provides an opportunity for participants to mention any additional thoughts or concerns they want to discuss with the chaplain interventionist.

Caregiver intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older;
• Able to read and speak English, as assessed by study staff;
• Has a phone (or has access to a phone);
• Provides daily care to a spouse, parent, or child with advanced disease - "care" includes day-to-day assistance and support, and "advanced disease" will be confirmed by a healthcare provider OR by a Palliative Performance Scale (PPS) score below 70%, as assessed by the caregiver (the patient will not be assessed);
• Cognitively capable to give informed consent, as determined by staff.

You may not qualify if:

• Caregivers of patients in hospice at time of consent (but if a patient enters hospice during the study, the caregiver may continue).

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27701, United States

Location

Study Officials

• Karen Steinhauser, PhD

  General Internal Medicine/Durham VA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: January 15, 2013
• Study Start: January 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 4, 2017

Record last verified: 2017-08

Locations

US (1)