Solid Organ TransplantNCT02165423
Discharge to Home and Chronic Illness Care Pilot
A study testing myFAMI iPad application in people with Solid Organ Transplant, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this study is to address a gap in knowledge needed for care of children with solid organ transplantation (SOT) and their parents by combining mHealth technology with an individualized family centered self-management intervention (referred to as myFAMI). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Solid Organ Transplant
- What is being tested?
- myFAMI iPad application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Oct 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- parent's child has undergone a heart, kidney, or liver transplant and is being discharged home from the hospital
- the parent is English speaking (to date the tools being used have been validated for English participants only)
- parent is 18 years of age or older
- patient is 17 years of age and younger.
Who cannot join
- presence of significant communication or cognitive impairment on the part of the parent that would preclude completion of questionnaires based on self-report
- parent and child has experienced the discharge to home transition from a previous transplant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
The purpose of this study is to address a gap in knowledge needed for care of children with solid organ transplantation (SOT) and their parents by combining mHealth technology with an individualized family centered self-management intervention (referred to as myFAMI). This study is critical to the increased understanding of hospital to home transition and family management at home with the potential to transform the way clinicians approach the care of complex chronic illness children and families.
- Conditions
- Solid Organ Transplant
- Being tested
- myFAMI iPad application
- Keywords
- pediatric, solid organ transplant, parents, heart, kidney, liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myFAMI iPad applicationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Ten parents will be randomized to the control group defined as 'usual care' and ten to the intervention group, stratified by type of transplant. Receives: Behavioral: myFAMI iPad application |
| Intervention | Experimental | Ten parents will be randomized to the control group defined as 'usual care' and ten to the intervention group, stratified by type of transplant. Receives: Behavioral: myFAMI iPad application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of myFAMI on 30-day post-discharge outcomes.
Hypothesis: Compared to parents who received standard discharge preparation (usual care), parents receiving myFAMI will report:
- Better care coordination, ii) Higher quality of discharge teaching, iii) Greater readiness for hospital discharge, iv) Improved post-discharge coping, v) Improved family functioning, vi) Better self-management of medication and treatment regimens vii) Fewer emergency department visits and hospital readmissions
Measured: 30 days following enrollment
Secondary outcomes (1)
Examine the acceptability of myFAMI:
- Examine the acceptability of myFAMI: The content of the interview will focus on strengths and weaknesses of iPad® technology in preparing parents for hospital discharge utilizing both survey and qualitative questions
Measured: Enrollment plus 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Organ TransplantStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's National Research Institute
- Responsible party
- Principal investigator, Stacee Lerret, Medical College of Wisconsin
- Investigators
- Stacee Lerret, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165423
- Sponsor's protocol ID
- CHW 14/66
- Status last verified
- Mar 2019
- First submitted
- 12 Jun 2014
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discharge to Home and Chronic Illness Care Pilot
- ClinicalTrials.gov ID
- NCT02165423
- Acronym / sponsor ID
- CHW 14/66
- Conditions
- Solid Organ Transplant
- Keywords
- pediatric, solid organ transplant, parents, heart, kidney, liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's National Research Institute
- Study start
- Jun 2014 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 17 Jun 2014 (estimated)
- 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.
The purpose of this study is to address a gap in knowledge needed for care of children with solid organ transplantation (SOT) and their parents by combining mHealth technology with an individualized family centered self-management intervention (referred to as myFAMI). This study is critical to the increased understanding of hospital to home transition and family management at home with the potential to transform the way clinicians approach the care of complex chronic illness children and families.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: myFAMI iPad applicationTen parents will be randomized to the control group defined as 'usual care' and ten to the intervention group, stratified by type of transplant. |
| Intervention | Experimental | Behavioral: myFAMI iPad applicationTen parents will be randomized to the control group defined as 'usual care' and ten to the intervention group, stratified by type of transplant. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- parent's child has undergone a heart, kidney, or liver transplant and is being discharged home from the hospital
- the parent is English speaking (to date the tools being used have been validated for English participants only)
- parent is 18 years of age or older
- patient is 17 years of age and younger.
Key exclusion criteria (2 listed)
- presence of significant communication or cognitive impairment on the part of the parent that would preclude completion of questionnaires based on self-report
- parent and child has experienced the discharge to home transition from a previous transplant.
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 |
|---|---|---|
| myFAMI iPad application | Behavioural | Control, Intervention |
Primary outcome
Evaluate the effectiveness of myFAMI on 30-day post-discharge outcomes.
Time frame: 30 days following enrollment
Hypothesis: Compared to parents who received standard discharge preparation (usual care), parents receiving myFAMI will report: i) Better care coordination, ii) Higher quality of discharge teaching, iii) Greater readiness for hospital discharge, iv) Improved post-discharge coping, v) Improved family functioning, vi) Better self-management of medication and treatment regimens vii) Fewer emergency department visits and hospital readmissions
1 secondary outcome
Examine the acceptability of myFAMI:
Time frame: Enrollment plus 30 days
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 7 Mar 2019.
Related trials for Solid Organ Transplant
Recruiting
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
RecruitingPhase 2
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
Immunization; Infection, Transplantation Infection
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
Active, not recruitingPhase 2
Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant
Solid Organ Transplant, Viral Infection
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
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.
Stacee Lerret, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myFAMI iPad application in people with Solid Organ Transplant, run by Medical College of Wisconsin 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 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 7 Mar 2019. 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?
Evaluate the effectiveness of myFAMI on 30-day post-discharge outcomes. (time frame: 30 days following enrollment). 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 7 Mar 2019.