Technology-enhanced Transitional Palliative Care for Family Caregivers

July 28, 2023 updated by: Joan M. Griffin, Mayo Clinic

Technology-enhanced Transitional Palliative Care for Family Caregivers in Rural Settings

The purpose of this study is to evaluate the effect and cost of technology-enhanced transitional palliative care on family caregivers who provide care to a loved one after a hospitalization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There will be two groups in this randomized control study: technology-enhanced group and usual care group. The total amount of subjects includes both the palliative care recipients and the family caregivers (both the patients and their family caregiver will sign informed consent.)

A family caregiver is broadly defined as the person self-identified as the family member or unpaid friend who is the primary informal caregiver for a patient with a terminal illness. The family caregiver may or may not be a member of the patient's nuclear family.

For the technology-enhanced group, the study nurse experienced in palliative care will have a visit with the caregiver within the first 24 hours after consent, and have daily visits with the caregiver as long as the patient is still in the hospital. During these visits, the nurse will talk to the caregiver about their own self-care needs, begin transitional care planning, and develop Readiness Plans to anticipate care giving needs the caregiver may have when they discharge from the hospital.

For the technology-enhanced group, the caregiver will take an iPad home so that the study team nurse can video chat with them. The iPad will need to be returned upon completion of the study. The study nurse will have a video chat with the caregiver at home within 24-48 hours of discharge from the hospital, and at least weekly for 8 weeks after that. The caregiver and the study nurse may also decide to have other calls on the phone during this time.

For the usual care group, doctors and nurses along with input from the Palliative Care service will help the caregiver make a plan for discharge from the hospital and for taking care of the patient upon discharge. Someone from the study team will call the caregiver once a month to check in for the 6 months after the patient discharges from the hospital.

Both groups will be asked to complete questionnaires before starting the study, and then up to seven more times over the course of 6 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
384

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult family caregiver of adult patient hospitalized at Mayo Clinic
  • Receives in-hospital palliative care consult
  • Family caregiver lives in a Minnesota or Iowa county that is designated as medically under served or rural area

Exclusion Criteria:

  • Family caregivers who live in Rochester, Minnesota. (Rochester, Minnesota is not considered a medically under served or rural area.)
  • Patients with left ventricular assistive devices, documented chronic pain, use of home infusion pain pumps, or documented addictive behaviors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Technology-Enhanced Group
Family caregivers will have daily visits from the study nurse while the patient is in the hospital and will receive weekly technology-enhanced support (video chats) from the study nurse for 8 weeks after the patient is discharged from the hospital.
Behavioral: Technology-Enhanced Support
The study nurse will meet with the caregiver daily until patient is discharged from the hospital. The caregiver will take home an iPad upon discharge, and will have an initial video chat with the study nurse within 24-48 hours of hospital discharge and weekly for 8 weeks after that.
Active Comparator: Usual Care Group
Family caregivers will have usual care support from the doctors and nurses to plan for taking care of the patient upon return home and will receive a weekly telephone call for 8 weeks after the patient is discharged from the hospital.
Behavioral: Usual Care Support
The patient's doctor and nurses with input from the Palliative Care service will help the caregiver make a plan for discharge of the patient, and for taking care of the patient upon discharge. Someone from the study team will call the caregiver once a month for the duration of the study after the patient discharges from the hospital.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Preparedness for Caregiving Scale Score
Time Frame: Baseline, 8 weeks
The Preparedness for Caregiving Scale captures how well family caregivers feel they are prepared for the multiple aspects of the caregiving role, using a 4-point response set ranging from 0 ("not at all") to 4 ("very well"). A mean score is calculated; higher scores indicate greater preparation for caregiving.
Baseline, 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Caregiver Quality of Life Scale - Cancer (CQOL-C) Score
Time Frame: baseline, 8 weeks
The Caregiver Quality of Life Scale - Cancer (CQOL-C) will be used to measure the family caregiver's quality of life. The CQOL-C is a 35-item self-report measure of the impact on the caregiver's physical, emotional and spiritual well-being and on the relationship with the care recipient. Scores range from 0-140; higher scores indicate worse quality of life.
baseline, 8 weeks
Change in Communication With Physicians Scale Score
Time Frame: baseline, 8 weeks
The Communication with Physicians scale will be used to measure the communication skills of the family caregiver. Originally designed for chronic disease self-management behavior, the scale has 3 questions targeting how often the family caregiver prepares a list of questions for the doctor, asks questions, and discusses personal problems across a 6-point response set ranging from "never" to "always." Scores range from 0-5 with higher scores indicating better communication.
baseline, 8 weeks
Mean Change in Patient Assessment of Chronic Illness Care (PACIC) Score
Time Frame: baseline, 8 weeks
The mean change in PACIC score. The PACIC was used to obtain family caregiver perceptions of the quality of chronic illness care received by the care recipient. The PACIC is a 20-item caregiver report instrument that measures caregivers' perspectives on the structure of the care for their care recipients and collects caregiver reports on the extent to which their care recipients have received specific clinical services and actions. Each question item is scored on a 5-point scale ranging from 1 to 5 with higher score indicating better care. Total scores range from 0 - 100, lower scores indicate worse care, higher scores indicate better care.
baseline, 8 weeks
Mean Change in Bakas Caregiving Outcomes Scale-Revised (BCOS-R) Score
Time Frame: baseline, 8 weeks
The mean change in BCOS-R score. The Bakas Caregiving Outcomes Scale-Revised (BCOS-R) was used to measure the burden placed on the family caregiver in caring for their loved ones. The BCOS-R contains 16 items that measure changes as indicators of the effect of caregiving on caregivers' lives. The response set uses a 7-point Likert scale that ranges from -3 to -1 = (changed for the worst), 0 = Did not change, +1 to +3 = (changed for the best). Total scores range from -48 to 48, lower scores indicate more negative caregiver outcomes, higher scores indicate more positive caregiver outcomes.
baseline, 8 weeks
Post Discharge Coping Difficulty Scale (PDCDS) Score
Time Frame: 2 weeks
The Post Discharge Coping Difficulty Scale (PDCDS) is a caregiver reported 11-item scale used to measure the degree of difficulty in coping with stress, recovery, self-care and management of medical needs, help and emotional support needed, confidence in self-care and medical management abilities, and adjustment after hospital discharge. The items are measured on an 11-point rating scale that ranges from 0 = Not at all to 10 = extremely, completely, or a great deal. Total scores range from 0 - 110 with lower scores indicating smaller coping difficulty and higher scores indicating greater coping difficulty.
2 weeks
Mean Change in Center for Epidemiological Studies Depression Scale (CESD-10) Score
Time Frame: baseline, 8 weeks
The mean change in CESD-10 score. The CESD-10 is a caregiver reported 10-item scale used to measure depression. Each question is scored on a 4-point scale, that ranges from 0 = none or rarely to 3 = all of the time. Total scores range from 0- 30, where 0 = no depression and 30 = the most depression.
baseline, 8 weeks
Mean Total Out-of-Pocket Expenditures at 6 Months
Time Frame: 6 months
The Ambulatory and Home Care Record (AHCR) will be used as the healthcare cost measure. The AHCR is designed to capture costs from a societal perspective, implying that costs from all stakeholders (family care givers, care recipients, and health systems) will be collected.The AHCR captures self-reported utilization and cost information for care provided by all family caregivers and other unpaid caregivers, paid care received at home (e.g., home health care) and outside of the home (e.g., doctor/therapy appointments),as well as medications, supplies, and equipment. Out-of-pocket costs refer to all care-related expenses not paid for by the insurance.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Diane E Holland, PhD, RN, Mayo Clinic
  • Principal Investigator: Joan M Griffin, Ph.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 5, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 5, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-005188
  • R01NR016433 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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