Palliative CareNCT03339271
Technology-enhanced Transitional Palliative Care for Family Caregivers
A study testing Technology-Enhanced Support in people with Palliative Care, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palliative Care
- What is being tested?
- Technology-Enhanced Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2018to 5 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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.
- Conditions
- Palliative Care
- Being tested
- Technology-Enhanced Support, Usual Care Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-Enhanced SupportBehavioural
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.
Usual Care SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Technology-Enhanced Group | Active comparator | 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. Receives: Behavioral: Technology-Enhanced Support |
| Usual Care Group | Active comparator | 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. Receives: Behavioral: Usual Care Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Preparedness for Caregiving Scale Score
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.
Measured: Baseline, 8 weeks
Secondary outcomes (7)
Change in Communication With Physicians Scale Score
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.
Measured: baseline, 8 weeks
Mean Change in Patient Assessment of Chronic Illness Care (PACIC) Score
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.
Measured: baseline, 8 weeks
Change in Caregiver Quality of Life Scale - Cancer (CQOL-C) Score
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.
Measured: baseline, 8 weeks
Mean Change in Bakas Caregiving Outcomes Scale-Revised (BCOS-R) Score
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.
Measured: baseline, 8 weeks
Post Discharge Coping Difficulty Scale (PDCDS) Score
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.
Measured: 2 weeks
Mean Change in Center for Epidemiological Studies Depression Scale (CESD-10) Score
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.
Measured: baseline, 8 weeks
Mean Total Out-of-Pocket Expenditures at 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start20 Mar 2018
- Primary completion5 Jul 2022
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Joan M. Griffin, Mayo Clinic
- Investigators
- Diane E Holland, PhD, RN, Principal investigator, Mayo ClinicJoan M Griffin, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339271
- Sponsor's protocol ID
- 17-005188
- Other IDs
- R01NR016433
- Status last verified
- Jul 2023
- First submitted
- 8 Nov 2017
- Last updated
- 21 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Griffin JM, Holland DE, Vanderboom CE, Kaufman BG, Gustavson AM, Ransom J, Mandrekar J, Dose AM, Ingram C, Fong ZV, Wild E, Weiss ME. Assessing Family Caregiver Readiness for Hospital Discharge of Patients With Serious or Life-Limiting Illness Using Electronic Health Record (EHR) and Self-Reported Data. Health Serv Res. 2025 Jan 28;60(4):e14441. doi: 10.1111/1475-6773.14441. Online ahead of print.
PubMed 39871699Kaufman BG, Zhang W, Shibeika S, Huang RW, Xu T, Ingram C, Gustavson AM, Holland DE, Vanderboom C, Van Houtven CH, Griffin JM. Economic Value of Unpaid Family Caregiver Time Following Hospital Discharge and at End of Life. J Pain Symptom Manage. 2024 Dec;68(6):632-640.e2. doi: 10.1016/j.jpainsymman.2024.08.030. Epub 2024 Aug 28.
PubMed 39209238Griffin JM, Mandrekar JN, Vanderboom CE, Harmsen WS, Kaufman BG, Wild EM, Dose AM, Ingram CJ, Taylor EE, Stiles CJ, Gustavson AM, Holland DE. Transitional Palliative Care for Family Caregivers: Outcomes From a Randomized Controlled Trial. J Pain Symptom Manage. 2024 Nov;68(5):456-466. doi: 10.1016/j.jpainsymman.2024.07.030. Epub 2024 Aug 5.
PubMed 39111586Kaufman BG, Huang RW, Holland DE, Vanderboom CE, Ingram C, Wild EM, Dose AM, Stiles C, Gustavson AM, Mandrekar J, Van Houtven CH, Griffin JM. Healthcare use and out-of-pocket costs for rural family caregivers and care recipients in a randomized controlled trial. J Am Geriatr Soc. 2024 Aug;72(8):2523-2531. doi: 10.1111/jgs.18934. Epub 2024 May 2.
PubMed 38698643Holland DE, Vanderboom CE, Mandrekar J, Borah BJ, Dose AM, Ingram CJ, Griffin JM. A technology-enhanced model of care for transitional palliative care versus attention control for adult family caregivers in rural or medically underserved areas: study protocol for a randomized controlled trial. Trials. 2020 Oct 28;21(1):895. doi: 10.1186/s13063-020-04806-0.
PubMed 33115524
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-enhanced Transitional Palliative Care for Family Caregivers in Rural Settings
- ClinicalTrials.gov ID
- NCT03339271
- Acronym / sponsor ID
- 17-005188
- Conditions
- Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Posted 21 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology-Enhanced Group | Active comparator | Behavioral: Technology-Enhanced SupportFamily 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. |
| Usual Care Group | Active comparator | Behavioral: Usual Care SupportFamily 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-Enhanced SupportThe 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. | Behavioural | Technology-Enhanced Group |
| Usual Care SupportThe 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. | Behavioural | Usual Care Group |
Primary outcome
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.
7 secondary outcomes
Change in Communication With Physicians Scale Score
Time frame: baseline, 8 weeks
Mean Change in Patient Assessment of Chronic Illness Care (PACIC) Score
Time frame: baseline, 8 weeks
Change in Caregiver Quality of Life Scale - Cancer (CQOL-C) Score
Time frame: baseline, 8 weeks
Mean Change in Bakas Caregiving Outcomes Scale-Revised (BCOS-R) Score
Time frame: baseline, 8 weeks
Post Discharge Coping Difficulty Scale (PDCDS) Score
Time frame: 2 weeks
Mean Change in Center for Epidemiological Studies Depression Scale (CESD-10) Score
Time frame: baseline, 8 weeks
Mean Total Out-of-Pocket Expenditures at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39871699Griffin JM, Holland DE, Vanderboom CE, Kaufman BG, Gustavson AM, Ransom J, Mandrekar J, Dose AM, Ingram C, Fong ZV, Wild E, Weiss ME. Assessing Family Caregiver Readiness for Hospital Discharge of Patients With Serious or Life-Limiting Illness Using Electronic Health Record (EHR) and Self-Reported Data. Health Serv Res. 2025 Jan 28;60(4):e14441. doi: 10.1111/1475-6773.14441. Online ahead of print.
- Derived from this study: PubMed 39209238Kaufman BG, Zhang W, Shibeika S, Huang RW, Xu T, Ingram C, Gustavson AM, Holland DE, Vanderboom C, Van Houtven CH, Griffin JM. Economic Value of Unpaid Family Caregiver Time Following Hospital Discharge and at End of Life. J Pain Symptom Manage. 2024 Dec;68(6):632-640.e2. doi: 10.1016/j.jpainsymman.2024.08.030. Epub 2024 Aug 28.
- Derived from this study: PubMed 39111586Griffin JM, Mandrekar JN, Vanderboom CE, Harmsen WS, Kaufman BG, Wild EM, Dose AM, Ingram CJ, Taylor EE, Stiles CJ, Gustavson AM, Holland DE. Transitional Palliative Care for Family Caregivers: Outcomes From a Randomized Controlled Trial. J Pain Symptom Manage. 2024 Nov;68(5):456-466. doi: 10.1016/j.jpainsymman.2024.07.030. Epub 2024 Aug 5.
- Derived from this study: PubMed 38698643Kaufman BG, Huang RW, Holland DE, Vanderboom CE, Ingram C, Wild EM, Dose AM, Stiles C, Gustavson AM, Mandrekar J, Van Houtven CH, Griffin JM. Healthcare use and out-of-pocket costs for rural family caregivers and care recipients in a randomized controlled trial. J Am Geriatr Soc. 2024 Aug;72(8):2523-2531. doi: 10.1111/jgs.18934. Epub 2024 May 2.
- Derived from this study: PubMed 33115524Holland DE, Vanderboom CE, Mandrekar J, Borah BJ, Dose AM, Ingram CJ, Griffin JM. A technology-enhanced model of care for transitional palliative care versus attention control for adult family caregivers in rural or medically underserved areas: study protocol for a randomized controlled trial. Trials. 2020 Oct 28;21(1):895. doi: 10.1186/s13063-020-04806-0.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane E Holland, PhD, RN principal investigator
Mayo Clinic
Joan M Griffin, Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-Enhanced Support in people with Palliative Care, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Preparedness for Caregiving Scale Score (time frame: Baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03339271, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.