Chronic Obstructive Pulmonary DiseaseHillmanNCT05611125
Nursing-Driven Primary Palliative Care for Urban-Dwelling African Americans With Chronic Lung Disease
A study testing Telehealth Integrated Primary Care (TIPC) in people with Chronic Obstructive Pulmonary Disease, run by Thomas Jefferson University at 1 site in United States.
Trial summary
In prior work, this research team developed a telehealth primary care model (TIPC), designed in close partnership with patients and clinicians to address a widespread increase in telehealth use during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Telehealth Integrated Primary Care (TIPC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD Diagnosis
- Age 18 years or older
Who cannot join
- Traumatic Brain Injuries
- Incarceration
- Homelessness
- Developmental disorders
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
In prior work, this research team developed a telehealth primary care model (TIPC), designed in close partnership with patients and clinicians to address a widespread increase in telehealth use during the COVID-19 pandemic. Researchers will test the TIPC intervention to assess palliative care (PC) support for patients with chronic obstructive pulmonary disease (COPD) among a population of urban-dwelling, African American (AA) persons over the course of 15 months.
The aims of this study are to 1) evaluate patient, caregiver, and clinical team perspectives of feasibility and acceptability of the TIPC model with urban-dwelling AAs with advanced COPD, and 2) explore the impact of TIPC intervention on knowledge and completion of advanced care planning (ACP) and on hospice and healthcare utilization patterns in the target population, as well as on additional quality of life (QOL) endpoints, and compare these between individuals participating in the intervention group and control group.
Read the detailed description
African Americans with chronic lung disease (CLD) experience higher-cost, lower-quality care (i.e. more untreated symptoms, poorer provider communication, care inconsistent with practices, lower hospice enrollment) compared to their white counterparts. Uptake of PC and ACP is also substantially lower amongst AAs and other underrepresented minorities (URMs) due to disparate access to information and mistrust in the healthcare system as generated by systemic, structural racism. Additionally, there are existing gaps in Jefferson's own PC program as revealed by our team's preliminary research into the program's level of cultural literacy. Interviews with black, indigenous people of color (BIPOC) enrolled with Jefferson PC revealed issues of clinician color blindness, an increased need for family engagement, and gaps in considering race and relationship to black pain in PC delivery.
This study will enroll 20 patients from Jefferson's Center City campuses. Half of the participants will be given the TIPC intervention, the other half will be assigned as controls who will receive their usual standard of care. All participants will be assessed over 6 months to assess changes in outcomes. Specifically amongst intervention patients, researchers will evaluate implementation outcomes (feasibility, acceptability, satisfaction, intervention uptake) of TIPC intervention at intervention start, post-visit 2, and 6 months after. Both intervention and control participants will be assessed for knowledge of ACP at 3 and 6 months, and health-related QOL, and caregiver burden at baseline, 3 months and 6 months.
Researchers will also measure clinical outcomes amongst both intervention and control patients (advance care planning and healthcare proxy designation, hospice use, avoidable healthcare utilization events) over 6 months.
Researchers will directly reach out to several departments including: Department of Medicine (Division of Pulmonary, Division of Hospital Medicine, and Division of Internal Medicine), Department of Family and Community Medicine, and Department of Emergency Medicine to identify patients (and, as applicable, their designated caregivers) for recruitment.
Once potential participants are identified, research team members will screen for eligibility criteria using EPIC. Recruitment will continue for all patients and caregivers until the anticipated enrollment goal for each group are reached (10 intervention, 10 controls).
Follow-up phone calls will be made to those who have not responded at approximately 3-7 day intervals.
Intervention subjects will partake in 2 telehealth visits as a part of the TIPC model. The first visit between patient, caregiver, and PC specialist will facilitate a patient-centered consultation guided by The Serious Illness Conversation Guide and involving patient completion of several PC assessments (i.e. Palliative Performance Scale,). The second visit between patient, caregiver, PC specialist and a pulmonology clinician/nurse will involve collaborative PC plan development and management and modeling of PC skills in an MDT framework.
This research team has trained staff to assess digital literacy and access barriers amongst all research participants. They will guide patients through accessing MyChart, creating an email (if needed), and perform test telehealth visits with patients prior to the scheduled clinical telehealth visits. If a patient is not able to connect at the time of their scheduled telehealth visit, a team member will call them via phone to again assist, as needed. This research team has ample experience with this, having created and deployed both the Telehealth Task Force (TTF) in the Sidney Kimmel Cancer Center (overseen by Dr. Worster) and the DOT (Digital Onboarding Taskforce) (overseen by Dr. Rising).
Evaluation of patient outcomes of the TIPC model will be ongoing across 6 months. Implementation outcomes will be measured amongst intervention patients. Feasibility, acceptability, and satisfaction collected via self-report will be collected at TIPC implementation and post-visit 2. Intervention uptake measured via chart review for references to the patient's PC plan in clinical encounters and PC plan-based referrals/adoptions will be analyzed over 6 months post-intervention.
Clinical outcomes will be measured for both subjects and controls. Advance care planning and healthcare proxy designation will be collected over 6 months via chart review, hospice use will be collected over 6 months via chart review for hospice enrollment and length of stay (LOS), and avoidable healthcare utilization events will be collected over 6 months via chart review for ED visits, urgent care (non-scheduled) visits, hospitalizations, and LOS with 'chief complaints' collected for each participant.
Additional follow-up outcomes of knowledge of ACP will be collected at 3 and 6 months and health-related QOL, and caregiver burden will be collected at baseline, 3 and 6 months for both subjects and controls via self-reporting.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Telehealth Integrated Primary Care (TIPC)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Integrated Primary Care (TIPC)Other
Also called TIPC
The TIPC model of intervention incorporates video visits across research clinicians and patients' existing care clinicians for more synergized and accessible care provision for a given clinical indication. The first TIPC visit will center around the patient setting care goals for themselves and their caregiver with the help of a palliative care physician. The second TIPC visit will focus on assessing goal attainment and also close the care loop between their existing care team, a research-appointed palliative care team, and their involvement in our study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Individuals in the intervention group will undergo a series of two telehealth video visits and a series of survey assessments at baseline, 3, and 6 months. Receives: Other: Telehealth Integrated Primary Care (TIPC) |
| Control | No intervention | Individuals in the control group will continue with their usual standard of care and undergo a series of survey assessments at baseline, 3, and 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Feasibility, Acceptability, Satisfaction regarding TIPC intervention as Assessed by Survey
Participants in the intervention group will report their experience with the TIPC model via survey questions. Participants will indicate whether or not they strongly disagree, disagree, have no opinion, agree, or strongly agree with a series of statements asking them about their experience with TIPC intervention.
Measured: 6 months
Secondary outcomes (11)
Change in Knowledge of Advanced Care Planning (ACP)
Participants will report the extent to which participating in video visits improved their knowledge regarding ACP. This will be assessed via a single-item statement that participants will say they either strongly disagree, disagree, have no opinion on, agree, or strongly agree with.
Measured: 3 months
Change in Knowledge of Advanced Care Planning (ACP)
Participants will report the extent to which participating in video visits improved their knowledge regarding ACP. This will be assessed via a single-item statement that participants will say they either strongly disagree, disagree, have no opinion on, agree, or strongly agree with.
Measured: 6 months
Change in Disease-Specific Quality of Life as Assessed by the CCQ
Participants report their disease-specific quality of life (QOL) by utilizing the Clinical COPD Questionnaire (CCQ). The CCQ measures COPD-specific QOL \& asks a variety of symptom-related questions. A summary index score is derived by applying an appropriate value set to the responses for each question (never/not limited at all=0, hardly ever/very slightly limited=0.1, a few times/slightly limited=0.2, several times/moderately limited=0.3, many times/very limited=0.4, a great many times/extremely limited=0.5, almost all the time/totally limited or unable to do=0.6). Pts can score up to 6 points with a higher score being negatively associated with a lower QOL.
Measured: Baseline
Change in Disease-Specific Quality of Life as Assessed by the CCQ
Participants report their disease-specific quality of life (QOL) by utilizing the Clinical COPD Questionnaire (CCQ). The CCQ measures COPD-specific QOL \& asks a variety of symptom-related questions. A summary index score is derived by applying an appropriate value set to the responses for each question (never/not limited at all=0, hardly ever/very slightly limited=0.1, a few times/slightly limited=0.2, several times/moderately limited=0.3, many times/very limited=0.4, a great many times/extremely limited=0.5, almost all the time/totally limited or unable to do=0.6). Pts can score up to 6 points with a higher score being negatively associated with a lower QOL.
Measured: 3 months
Change in Disease-Specific Quality of Life as Assessed by the CCQ
Participants report their disease-specific quality of life (QOL) by utilizing the Clinical COPD Questionnaire (CCQ). The CCQ measures COPD-specific QOL \& asks a variety of symptom-related questions. A summary index score is derived by applying an appropriate value set to the responses for each question (never/not limited at all=0, hardly ever/very slightly limited=0.1, a few times/slightly limited=0.2, several times/moderately limited=0.3, many times/very limited=0.4, a great many times/extremely limited=0.5, almost all the time/totally limited or unable to do=0.6). Pts can score up to 6 points with a higher score being negatively associated with a lower QOL.
Measured: 6 months
Change in General Quality of Life as Assessed by the FACIT-Pal
Participants report their quality of life (QOL) by utilizing the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal). FACIT-Pal measures areas that include physical, social/family, emotional, \& functional well-beings. A summary index score is derived by applying an appropriate value set to the responses for each question (not at all=0, a little bit=1, somewhat=2, quite a bit=3, very much=4). Pts can score up to 184 points with a higher score being associated with a higher QOL.
Measured: Baseline
Change in General Quality of Life as Assessed by the FACIT-Pal
Participants report their quality of life (QOL) by utilizing the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal). FACIT-Pal measures areas that include physical, social/family, emotional, \& functional well-beings. A summary index score is derived by applying an appropriate value set to the responses for each question (not at all=0, a little bit=1, somewhat=2, quite a bit=3, very much=4). Pts can score up to 184 points with a higher score being associated with a higher QOL.
Measured: 3 months
Change in General Quality of Life as Assessed by the FACIT-Pal
Participants report their quality of life (QOL) by utilizing the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal). FACIT-Pal measures areas that include physical, social/family, emotional, \& functional well-beings. A summary index score is derived by applying an appropriate value set to the responses for each question (not at all=0, a little bit=1, somewhat=2, quite a bit=3, very much=4). Pts can score up to 184 points with a higher score being associated with a higher QOL.
Measured: 6 months
Change in Caregiver Burden
Participating caregivers will explore how taking care of their loved ones has impacted their daily lives via the Caregiver Strain Index (CSI). The CSI measures areas that include but are not limited to sleep hygiene, convenience of care, physical strain, family adjustments as a result of care, financial burden, and more. A summary index score is derived by applying an appropriate value set to the responses for each question (yes=1, no=0). Patients can score up to 12 points with a score of 7 or higher being associated with a higher level of caregiver burden experienced.
Measured: Baseline
Change in Caregiver Burden
Participating caregivers will explore how taking care of their loved ones has impacted their daily lives via the Caregiver Strain Index (CSI). The CSI measures areas that include but are not limited to sleep hygiene, convenience of care, physical strain, family adjustments as a result of care, financial burden, and more. A summary index score is derived by applying an appropriate value set to the responses for each question (yes=1, no=0). Patients can score up to 12 points with a score of 7 or higher being associated with a higher level of caregiver burden experienced.
Measured: 3 months
Change in Caregiver Burden
Participating caregivers will explore how taking care of their loved ones has impacted their daily lives via the Caregiver Strain Index (CSI). The CSI measures areas that include but are not limited to sleep hygiene, convenience of care, physical strain, family adjustments as a result of care, financial burden, and more. A summary index score is derived by applying an appropriate value set to the responses for each question (yes=1, no=0). Patients can score up to 12 points with a score of 7 or higher being associated with a higher level of caregiver burden experienced.
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 posted9 Nov 2022
- Study start2 Dec 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Rita & Alex Hillman Foundation
- Responsible party
- Principal investigator, Jeannette Kates, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611125
- Sponsor's protocol ID
- 083-51020-U32301
- Other IDs
- #22G.350
- Acronym
- Hillman
- Status last verified
- Feb 2024
- First submitted
- 27 Sep 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing-Driven Primary Palliative Care for Urban-Dwelling African Americans With Chronic Lung Disease
- ClinicalTrials.gov ID
- NCT05611125
- Acronym / sponsor ID
- Hillman / 083-51020-U32301
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Rita & Alex Hillman Foundation
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In prior work, this research team developed a telehealth primary care model (TIPC), designed in close partnership with patients and clinicians to address a widespread increase in telehealth use during the COVID-19 pandemic. Researchers will test the TIPC intervention to assess palliative care (PC) support for patients with chronic obstructive pulmonary disease (COPD) among a population of urban-dwelling, African American (AA) persons over the course of 15 months.
The aims of this study are to 1) evaluate patient, caregiver, and clinical team perspectives of feasibility and acceptability of the TIPC model with urban-dwelling AAs with advanced COPD, and 2) explore the impact of TIPC intervention on knowledge and completion of advanced care planning (ACP) and on hospice and healthcare utilization patterns in the target population, as well as on additional quality of life (QOL) endpoints, and compare these between individuals participating in the intervention group and control group.
Detailed description
African Americans with chronic lung disease (CLD) experience higher-cost, lower-quality care (i.e. more untreated symptoms, poorer provider communication, care inconsistent with practices, lower hospice enrollment) compared to their white counterparts. Uptake of PC and ACP is also substantially lower amongst AAs and other underrepresented minorities (URMs) due to disparate access to information and mistrust in the healthcare system as generated by systemic, structural racism. Additionally, there are existing gaps in Jefferson's own PC program as revealed by our team's preliminary research into the program's level of cultural literacy. Interviews with black, indigenous people of color (BIPOC) enrolled with Jefferson PC revealed issues of clinician color blindness, an increased need for family engagement, and gaps in considering race and relationship to black pain in PC delivery.
This study will enroll 20 patients from Jefferson's Center City campuses. Half of the participants will be given the TIPC intervention, the other half will be assigned as controls who will receive their usual standard of care. All participants will be assessed over 6 months to assess changes in outcomes. Specifically amongst intervention patients, researchers will evaluate implementation outcomes (feasibility, acceptability, satisfaction, intervention uptake) of TIPC intervention at intervention start, post-visit 2, and 6 months after. Both intervention and control participants will be assessed for knowledge of ACP at 3 and 6 months, and health-related QOL, and caregiver burden at baseline, 3 months and 6 months.
Researchers will also measure clinical outcomes amongst both intervention and control patients (advance care planning and healthcare proxy designation, hospice use, avoidable healthcare utilization events) over 6 months.
Researchers will directly reach out to several departments including: Department of Medicine (Division of Pulmonary, Division of Hospital Medicine, and Division of Internal Medicine), Department of Family and Community Medicine, and Department of Emergency Medicine to identify patients (and, as applicable, their designated caregivers) for recruitment.
Once potential participants are identified, research team members will screen for eligibility criteria using EPIC. Recruitment will continue for all patients and caregivers until the anticipated enrollment goal for each group are reached (10 intervention, 10 controls).
Follow-up phone calls will be made to those who have not responded at approximately 3-7 day intervals.
Intervention subjects will partake in 2 telehealth visits as a part of the TIPC model. The first visit between patient, caregiver, and PC specialist will facilitate a patient-centered consultation guided by The Serious Illness Conversation Guide and involving patient completion of several PC assessments (i.e. Palliative Performance Scale,). The second visit between patient, caregiver, PC specialist and a pulmonology clinician/nurse will involve collaborative PC plan development and management and modeling of PC skills in an MDT framework.
This research team has trained staff to assess digital literacy and access barriers amongst all research participants. They will guide patients through accessing MyChart, creating an email (if needed), and perform test telehealth visits with patients prior to the scheduled clinical telehealth visits. If a patient is not able to connect at the time of their scheduled telehealth visit, a team member will call them via phone to again assist, as needed. This research team has ample experience with this, having created and deployed both the Telehealth Task Force (TTF) in the Sidney Kimmel Cancer Center (overseen by Dr. Worster) and the DOT (Digital Onboarding Taskforce) (overseen by Dr. Rising).
Evaluation of patient outcomes of the TIPC model will be ongoing across 6 months. Implementation outcomes will be measured amongst intervention patients. Feasibility, acceptability, and satisfaction collected via self-report will be collected at TIPC implementation and post-visit 2. Intervention uptake measured via chart review for references to the patient's PC plan in clinical encounters and PC plan-based referrals/adoptions will be analyzed over 6 months post-intervention.
Clinical outcomes will be measured for both subjects and controls. Advance care planning and healthcare proxy designation will be collected over 6 months via chart review, hospice use will be collected over 6 months via chart review for hospice enrollment and length of stay (LOS), and avoidable healthcare utilization events will be collected over 6 months via chart review for ED visits, urgent care (non-scheduled) visits, hospitalizations, and LOS with 'chief complaints' collected for each participant.
Additional follow-up outcomes of knowledge of ACP will be collected at 3 and 6 months and health-related QOL, and caregiver burden will be collected at baseline, 3 and 6 months for both subjects and controls via self-reporting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Telehealth Integrated Primary Care (TIPC)Individuals in the intervention group will undergo a series of two telehealth video visits and a series of survey assessments at baseline, 3, and 6 months. |
| Control | No intervention | –Individuals in the control group will continue with their usual standard of care and undergo a series of survey assessments at baseline, 3, and 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD Diagnosis
- Age 18 years or older
Key exclusion criteria (5 listed)
- Traumatic Brain Injuries
- Incarceration
- Homelessness
- Developmental disorders
- Pregnancy
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 |
|---|---|---|
| Telehealth Integrated Primary Care (TIPC)Also: TIPCThe TIPC model of intervention incorporates video visits across research clinicians and patients' existing care clinicians for more synergized and accessible care provision for a given clinical indication. The first TIPC visit will center around the patient setting care goals for themselves and their caregiver with the help of a palliative care physician. The second TIPC visit will focus on assessing goal attainment and also close the care loop between their existing care team, a research-appointed palliative care team, and their involvement in our study. | Other | Intervention |
Primary outcome
Change in Feasibility, Acceptability, Satisfaction regarding TIPC intervention as Assessed by Survey
Time frame: 6 months
Participants in the intervention group will report their experience with the TIPC model via survey questions. Participants will indicate whether or not they strongly disagree, disagree, have no opinion, agree, or strongly agree with a series of statements asking them about their experience with TIPC intervention.
11 secondary outcomes
Change in Knowledge of Advanced Care Planning (ACP)
Time frame: 3 months
Change in Knowledge of Advanced Care Planning (ACP)
Time frame: 6 months
Change in Disease-Specific Quality of Life as Assessed by the CCQ
Time frame: Baseline
Change in Disease-Specific Quality of Life as Assessed by the CCQ
Time frame: 3 months
Change in Disease-Specific Quality of Life as Assessed by the CCQ
Time frame: 6 months
Change in General Quality of Life as Assessed by the FACIT-Pal
Time frame: Baseline
Change in General Quality of Life as Assessed by the FACIT-Pal
Time frame: 3 months
Change in General Quality of Life as Assessed by the FACIT-Pal
Time frame: 6 months
Change in Caregiver Burden
Time frame: Baseline
Change in Caregiver Burden
Time frame: 3 months
Change in Caregiver Burden
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Integrated Primary Care (TIPC) in people with Chronic Obstructive Pulmonary Disease, run by Thomas Jefferson University 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 2 inclusion and 5 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 6 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Feasibility, Acceptability, Satisfaction regarding TIPC intervention as Assessed by Survey (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2024.