Adherence, PatientNCT04887779
Pathologist Lung Transplant Study
A study testing Pathologist intervention in people with Adherence, Patient and Psychological, run by University of Pittsburgh at 1 site in United States.
Trial summary
Using a prospective qualitative approach, explore whether pathologist intervention is feasible as part of multimodal multidisciplinary care model for transplant patients in effecting psychological dimensions such as experience, satisfaction, or patient's understanding of their disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adherence, Patient, Psychological, Coping Skills
- What is being tested?
- Pathologist intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2021to 1 Aug 2022
- 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
- Lung transplant patient, transplanted after IRB approval of study -Transplanted primarily for COPD
- English speaking
- within three months of initial transplant (prior to initial discharge)
- > 18 years old
Who cannot join
- Transplant indication other than COPD
- <18 year old
- Non English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Pathologist Led Intervention To Improve Psychological Outcomes and Adherence in Lung Transplant Patients
Using a prospective qualitative approach, explore whether pathologist intervention is feasible as part of multimodal multidisciplinary care model for transplant patients in effecting psychological dimensions such as experience, satisfaction, or patient's understanding of their disease. Additionally, to examine if this intervention improves medication adherence.
Read the detailed description
Specific Aims 1. Create post-transplant pathologist-led intervention Objective 1a: Recruit 10 patients who have undergone lung transplantation primarily for chronic obstructive pulmonary disease (COPD). Use pathologist to show gross/microscopic explanted organs.
Specific Aim 2. Assess the efficacy of intervention pilot Objective 2a: Immediate (within 1 day after pathologist intervention) phone interview to access patient's reaction, feelings, and experience with intervention and understanding of disease.
Objective 2b: 1 month later, phone interview asking questions related to medication adherence, patient experience with intervention and lung transplant overall, and patient understanding of disease. Results will be compared to first interview.
Objective 2c: Analyze Client Satisfaction Questionnaire (CSQ-8) for quality of life, Basel assessment of adherence to immunosuppressive medications scale (BAASIS) as a self report adherence measure, and conduct a mixed methods/grounded theory analysis of qualitative data (patient experience, disease understanding). This analysis will systematically identify themes, and assign these descriptive words.
Specific Aim 3: Finalize intervention protocol based on pilot testing. Objective 3a. Adjust and refine the content and process of intervention protocol based on findings of pilot study Objective 3b. Final changes will assure readiness for large scale study.
- Conditions
- Adherence, Patient, Psychological, Coping Skills
- Being tested
- Pathologist intervention
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathologist interventionBehavioural
viewing explanted organ and microscopy
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patient viewing ex-planted organ and microscopy with pathologist Receives: Behavioral: Pathologist intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS©)
The Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS©) was developed to assess adherence to immunosuppressive drugs in adult and adolescent transplant recipients. Initiation starts when a patient takes his/her first dose of medication. This is a binary event (yes/no). Implementation of the dosing regimen refers to "the extent to which a patient's actual dosing corresponds to the prescribed dosing regimen, from initiation until the last dose is taken" and implies a dosing history.
Discontinuation refers to "the moment that the patient discontinues his/her medication regimen" and is assessed as a time to event. Persistence is thus the duration between time of initiation and the moment the last dose is taken. Any yes response demonstrates issues with medication adherence.
Measured: one day after intervention and assessment for change one month later
Client Satisfaction Questionnaire (CSQ-8)
The Client Satisfaction Questionnaire is an 8 item measure of client satisfaction. An "overall score" is calculated by summing the respondent's rating (item rating) score for each scale item. Scores therefore range from 8 to 32, with higher values indicating higher satisfaction. with services with both a parent intervention versus averages of lung transplant patients.
Measured: one day after intervention and assessment for change one month later
Secondary outcomes (2)
Patient understanding
Assess if patient has gained more understanding of their condition. No specific scale used, assessed by interview.
Measured: one day after intervention and assessment for change one month later
Patient experience
Discussing patient's overall experience. No specific scale used, assessed by interview.
Measured: one day after intervention and assessment for change one month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study startDec 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Why it stopped: personale shortage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, PatientStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, no blinding or randomization
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blake Gibson, University of Pittsburgh
- Investigators
- Blake Gibson, MD, Principal investigator, University of Pittsburgh Medical Center Western Psychiatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887779
- Sponsor's protocol ID
- STUDY19060024
- Status last verified
- Feb 2022
- First submitted
- 11 May 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathologist Led Intervention To Improve Psychological Outcomes and Adherence in Lung Transplant Patients
- ClinicalTrials.gov ID
- NCT04887779
- Acronym / sponsor ID
- STUDY19060024
- Conditions
- Adherence, Patient, Psychological, Coping Skills
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: personale shortage
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 14 May 2021 (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.
Using a prospective qualitative approach, explore whether pathologist intervention is feasible as part of multimodal multidisciplinary care model for transplant patients in effecting psychological dimensions such as experience, satisfaction, or patient's understanding of their disease. Additionally, to examine if this intervention improves medication adherence.
Detailed description
Specific Aims 1. Create post-transplant pathologist-led intervention Objective 1a: Recruit 10 patients who have undergone lung transplantation primarily for chronic obstructive pulmonary disease (COPD). Use pathologist to show gross/microscopic explanted organs.
Specific Aim 2. Assess the efficacy of intervention pilot Objective 2a: Immediate (within 1 day after pathologist intervention) phone interview to access patient's reaction, feelings, and experience with intervention and understanding of disease.
Objective 2b: 1 month later, phone interview asking questions related to medication adherence, patient experience with intervention and lung transplant overall, and patient understanding of disease. Results will be compared to first interview.
Objective 2c: Analyze Client Satisfaction Questionnaire (CSQ-8) for quality of life, Basel assessment of adherence to immunosuppressive medications scale (BAASIS) as a self report adherence measure, and conduct a mixed methods/grounded theory analysis of qualitative data (patient experience, disease understanding). This analysis will systematically identify themes, and assign these descriptive words.
Specific Aim 3: Finalize intervention protocol based on pilot testing. Objective 3a. Adjust and refine the content and process of intervention protocol based on findings of pilot study Objective 3b. Final changes will assure readiness for large scale study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, no blinding or randomization
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Pathologist interventionPatient viewing ex-planted organ and microscopy with pathologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Lung transplant patient, transplanted after IRB approval of study -Transplanted primarily for COPD
- English speaking
- within three months of initial transplant (prior to initial discharge)
- > 18 years old
Key exclusion criteria (3 listed)
- Transplant indication other than COPD
- <18 year old
- Non English speaking
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 |
|---|---|---|
| Pathologist interventionviewing explanted organ and microscopy | Behavioural | Intervention |
Primary outcome
Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS©)
Time frame: one day after intervention and assessment for change one month later
The Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS©) was developed to assess adherence to immunosuppressive drugs in adult and adolescent transplant recipients. Initiation starts when a patient takes his/her first dose of medication. This is a binary event (yes/no). Implementation of the dosing regimen refers to "the extent to which a patient's actual dosing corresponds to the prescribed dosing regimen, from initiation until the last dose is taken" and implies a dosing history. Discontinuation refers to "the moment that the patient discontinues his/her medication regimen" and is assessed as a time to event. Persistence is thus the duration between time of initiation and the moment the last dose is taken. Any yes response demonstrates issues with medication adherence.
Client Satisfaction Questionnaire (CSQ-8)
Time frame: one day after intervention and assessment for change one month later
The Client Satisfaction Questionnaire is an 8 item measure of client satisfaction. An "overall score" is calculated by summing the respondent's rating (item rating) score for each scale item. Scores therefore range from 8 to 32, with higher values indicating higher satisfaction. with services with both a parent intervention versus averages of lung transplant patients.
2 secondary outcomes
Patient understanding
Time frame: one day after intervention and assessment for change one month later
Patient experience
Time frame: one day after intervention and assessment for change one month later
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Blake Gibson, MD principal investigator
University of Pittsburgh Medical Center Western Psychiatric Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pathologist intervention in people with Adherence, Patient and Psychological, run by University of Pittsburgh 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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 21 Feb 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS©) (time frame: one day after intervention and assessment for change one month later). The study lists 2 primary outcomes in all. 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 21 Feb 2022.