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A Problem Solving Intervention for Hospice Caregivers

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ClinicalTrials.gov Identifier: NCT03712410
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 29, 2018
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
George Demiris, PhD, University of Pennsylvania

Brief Summary:
Hospice care is conceptualized as quality compassionate care for people facing a life-limiting illness, with services that cover clinical care, pain management, and emotional and spiritual support tailored to patients' and families' needs and preferences. Family members, spouses, friends or others who assume the unpaid or informal caregiving role are essential to the delivery of hospice services; however, stress and caregiver burden can negatively affect caregivers' morbidity and mortality. The emotional needs of individuals caring for dying persons at home are not well attended, and interventions aiming to provide support to hospice caregivers are notably lacking. The investigator team recently completed a study with 514 hospice caregivers to test a problem-solving therapy (PST) intervention tailored specifically for the hospice setting, entitled PISCES (Problem-solving Intervention to Support Caregivers in End of Life care Settings). The findings demonstrate that the PISCES intervention when delivered face to face was effective leading to statistically significant decrease in anxiety and increase in quality of life when compared to the other groups (video group and attention control). An additional lesson learned from that RCT study was that caregivers wanted to focus not only on specific problems or challenges, but also on recognizing the positive aspects of caregiving. This approach of positive reappraisal has been found to enhance problem solving interventions in other settings. The specific aims of this new study are: 1) to compare the effectiveness of the PISCES intervention when delivered face to face and when delivered in a hybrid platform (with the first session in person and remaining sessions via video) to hospice caregivers; 2) to compare the effectiveness of the PISCES intervention to the refined PISCES intervention (PISCESplus) that integrates positive reappraisal elements; 3) to assess caregivers' perceptions of and satisfaction with the PISCESplus intervention; and 4) to conduct a cost analysis of the three intervention groups.

Condition or disease Intervention/treatment Phase
Anxiety Generalized Quality of Life Depression Behavioral: PISCES Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Problem Solving Intervention for Hospice Caregivers
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1 (PISCES face to face)
Family caregivers will receive three sessions of the PISCES intervention in person. The agenda for the first face to face visit for caregivers (suggested timeline 5-7 days after hospice admission) includes an explanation of the purpose of the visit/call. During the first session, the interventionist works on steps one and two of the ADAPT model, namely "Attitude" and "Defining the Problem and Setting Realistic Goals." During the second visit (suggested timeline 11-13 days after hospice admission) the interventionist covers steps three and four of the ADAPT model. Step three encourages caregivers in being creative and generating alternative solutions. Step four focuses on predicting the consequences and developing a solution plan. The third visit (suggested timeline 16-18 days after hospice admission) focuses on step five, namely trying out the solution plan and determining if it works.
Behavioral: PISCES
The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients.

Experimental: Group 2 (PISCES delivered in a hybrid format)
In this group, participants will receive the PISCES intervention in three sessions; however, the first session will be delivered face to face and the other two via video. The three intervention sessions will be scheduled with a suggested timeline between days 5 and 18 of the hospice admission. The first session will take place in person (suggested timeline 5-7 days after hospice admission). After the first session where the in-person encounter will allow for the establishment of rapport between the interventionist and the caregiver, the second session (suggested timeline 11-13 days after hospice admission) and the third session (suggested timeline 16-18 days after hospice admissions) will be conducted via live videoconferencing. If the caregiver already has access to a computer and Internet, they will utilize the videoconferencing solution. If videoconferencing is not feasible, the sessions will be delivered over the regular phone.
Behavioral: PISCES
The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients.

Experimental: Group 3 (PISCESplus)

PISCESplus is meant to be an enhanced version of the PISCES intervention including the original problem solving therapy modules with the addition of positive reappraisal elements. The suggested timeline for the first session which will be in person is 5-7 days after hospice admission. At the end of the first session, the interventionist will ask the caregiver to take the time to think about and identify some positive aspects of caregiving.

At the end of the second session (which is scheduled to take place via video approx. 11-13 days after admission) the interventionist will ask the caregiver to go over the benefits or positive aspects of caregiving that they had identified and ask them to comment as to why they perceive these as positive or beneficial.

The third session will also take place via video.

Behavioral: PISCES
The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients.




Primary Outcome Measures :
  1. Change in Anxiety [ Time Frame: through study completion, an average of a month ]
    measuring changes in anxiety using the Generalized Anxiety Disorder 7-item questionnaire (GAD-7)

  2. Changes in Caregiver Quality of Life: Caregiver QoL Index [ Time Frame: through study completion, an average of a month ]
    Changes in quality of life using the Caregiver Quality of Life-Index (Revised) scale

  3. Changes in Depression [ Time Frame: through study completion, an average of a month ]
    Changes in Depression Scores using the Patient Health Questionnaire 9 items (PHQ-9)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The investigator's inclusion criteria cover all genders (and gender is based on self-representation of gender identity).
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • enrolled as a family/informal caregiver of a hospice patient
  • 18 years or older
  • with access to a standard phone line or Internet and computer access at home
  • without functional hearing loss or with a hearing aid that allows the participant to conduct telephone conversations as assessed by the research staff (by questioning and observing the caregiver)
  • speak and read English, with at least a 6th-grade education

Exclusion Criteria:

  • hearing or visual impairment that prohibits from conducting phone conversations or video conference sessions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712410


Contacts
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Contact: George Demiris, PhD 2158988559 gdemiris@upenn.edu
Contact: Stacey D Brown, MSW 2157468226 sdjbrown@nursing.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: George Demiris, PhD    215-898-8559    gdemiris@upenn.edu   
Sponsors and Collaborators
George Demiris, PhD
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: George Demiris, PhD University of Pennsylvania

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Responsible Party: George Demiris, PhD, PIK Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03712410     History of Changes
Other Study ID Numbers: 828990
R01NR012213-06 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No