Complications of Transplanted Organs and TissueNCT02605200
Identification and Treatment of Diabetes In Solid Organ Transplant Recipients
A study testing Psychologist Support and Pediatric Certified Diabetes Educators (CDEs) Support in people with Complications of Transplanted Organs and Tissue, run by Emory University at 2 sites in United States.
Trial summary
The purpose of this study is to determine the influence of post-transplant diabetes on medical and psychosocial outcomes in individuals who receive solid-organ transplant prior to 18 years of age and their families. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Complications of Transplanted Organs and Tissue
- What is being tested?
- Psychologist Support and Pediatric Certified Diabetes Educators (CDEs) Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jul 2016to 14 Nov 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients of Children's Healthcare of Atlanta who have received a kidney, liver, or heart transplant
Who cannot join
- Received a transplant after 18 years of age
- Cognitively unable to participant as determined by the study team psychologist
- Not receiving a solid organ transplant for kidney, liver, or heart
- Declines participation invitation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Healthcare of Atlanta-Egleston
Atlanta, Georgia, 30322
Emory Children's Center
Atlanta, Georgia, 30322
About this study
The purpose of this study is to determine the influence of post-transplant diabetes on medical and psychosocial outcomes in individuals who receive solid-organ transplant prior to 18 years of age and their families.
Read the detailed description
This study seeks to understand how organ transplant patients are affected by the development of diabetes, and to test whether early diagnosis of diabetes and comprehensive professional support will:
- facilitate the adjustment of children and their families to the rigors of diabetes care
- improve adherence to medication regimens
- reduce acute complications of diabetes and organ rejection.
- Being tested
- Psychologist Support, Pediatric Certified Diabetes Educators (CDEs) Support
- Keywords
- Diabetes, Endocrinology, Pediatrics
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychologist SupportBehavioural
Participants will complete several psychological questionnaires that are intended to cover a broad spectrum of physical, mental, and emotional aspects of the health of participants; the Behavior Assessment System for Children (BASC) ,the Children Depression Inventory (CDI 2), the Pediatric Quality of Life Inventory Transplant Module (PedsQL), and the Wechsler Abbreviated Scale of Intelligence II (WASI-II). Data gathered from this testing will be used to guide the provision of psychological care to address psychosocial challenges inherent to the care of children with transplant related diabetes.
Pediatric Certified Diabetes Educators (CDEs) SupportBehavioural
Pediatric Certified Diabetes Educators (CDEs) are specially trained to teach diabetes self-management to children and their families. Participants who are diagnosed with diabetes will receive individualized support from a CDE in conjunction with their routine transplant care.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Other | Participants will complete tests of glucose tolerance and psychosocial assessments, and will undergo medical history screening. Those children identified with diabetes and/or abnormal glucose tolerance will receive both diabetes self-management education and psychosocial support from a pediatric Certified Diabetes Educator (CDE) and a psychologist, respectively. Receives: Behavioral: Psychologist Support; Behavioral: Pediatric Certified Diabetes Educators (CDEs) Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Pediatric Quality of Life Inventory Transplant Module (PedsQL)
The Pediatric Quality of Life Inventory Transplant Module (PedsQL) is a 15 minute survey intended to measure emotional and physical function in children and determine state of wellbeing.
Measured: Baseline, interval, and end of participation (Up to 18 years of age)
Secondary outcomes (6)
Transplant Rejection Rate Post Diabetes Diagnosis
Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of transplant rejection after being diagnosed with diabetes.
Measured: Up to three years
Rate of Vascular Disease Post Diabetes Diagnosis
Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of vascular disease after being diagnosed with diabetes.
Measured: Up to three years
Mortality Rate Post Diabetes Diagnosis
Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of mortality after being diagnosed with diabetes.
Measured: Up to three years
Change in the Wechsler Abbreviated Scale of Intelligence II (WASI-II) Score
The Wechsler Abbreviated Scale of Intelligence II (WASI-II) is intended to determine cognitive ability for use in educational, as well as clinical and research settings. The WASI-II is ideal for any subject over the age of six, and takes approximately one hour to complete.
Measured: Baseline, interval, and end of participation (Up to 18 years)
Change in the Children Depression Inventory (CDI 2) Score
The Children Depression Inventory (CDI 2) is a short ten minute self-reported survey intended to aid in the assessment of signs of depression in children ages seven through 17. This test helps determine negative mood, poor self-esteem, a loss of interest in activities, interpersonal problems, and feelings of ineffectiveness, the common traits of depression.
Measured: Baseline, interval, and end of participation (Up to 18 years)
Change in the Behavior Assessment System for Children (BASC) Score
The Behavior Assessment System for Children (BASC) takes approximately 15 minutes to complete and is intended to determine emotional and behavioral change in children, as well as to indicate risks to their health and development
Measured: Baseline, interval, and end of participation (Up to 18 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study start7 Jul 2016
- Primary completion14 Nov 2018
- Study completion14 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications of Transplanted Organs and TissueStudies of the same condition, open and under way.
- More trials run by Emory 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jee-Young Nina Ham, Emory University
- Investigators
- Nina Ham, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605200
- Sponsor's protocol ID
- IRB00081257
- Status last verified
- Dec 2020
- First submitted
- 6 Oct 2015
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Treatment of Diabetes In Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT02605200
- Acronym / sponsor ID
- IRB00081257
- Keywords
- Diabetes, Endocrinology, Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 7 Jul 2016 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 16 Nov 2015 (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 determine the influence of post-transplant diabetes on medical and psychosocial outcomes in individuals who receive solid-organ transplant prior to 18 years of age and their families.
Detailed description
This study seeks to understand how organ transplant patients are affected by the development of diabetes, and to test whether early diagnosis of diabetes and comprehensive professional support will:
- facilitate the adjustment of children and their families to the rigors of diabetes care
- improve adherence to medication regimens
- reduce acute complications of diabetes and organ rejection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Other | Behavioral: Psychologist Support, Behavioral: Pediatric Certified Diabetes Educators (CDEs) SupportParticipants will complete tests of glucose tolerance and psychosocial assessments, and will undergo medical history screening. Those children identified with diabetes and/or abnormal glucose tolerance will receive both diabetes self-management education and psychosocial support from a pediatric Certified Diabetes Educator (CDE) and a psychologist, respectively. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients of Children's Healthcare of Atlanta who have received a kidney, liver, or heart transplant
Key exclusion criteria (4 listed)
- Received a transplant after 18 years of age
- Cognitively unable to participant as determined by the study team psychologist
- Not receiving a solid organ transplant for kidney, liver, or heart
- Declines participation invitation
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 |
|---|---|---|
| Psychologist SupportParticipants will complete several psychological questionnaires that are intended to cover a broad spectrum of physical, mental, and emotional aspects of the health of participants; the Behavior Assessment System for Children (BASC) ,the Children Depression Inventory (CDI 2), the Pediatric Quality of Life Inventory Transplant Module (PedsQL), and the Wechsler Abbreviated Scale of Intelligence II (WASI-II). Data gathered from this testing will be used to guide the provision of psychological care to address psychosocial challenges inherent to the care of children with transplant related diabetes. | Behavioural | Participants |
| Pediatric Certified Diabetes Educators (CDEs) SupportPediatric Certified Diabetes Educators (CDEs) are specially trained to teach diabetes self-management to children and their families. Participants who are diagnosed with diabetes will receive individualized support from a CDE in conjunction with their routine transplant care. | Behavioural | Participants |
Primary outcome
Change in the Pediatric Quality of Life Inventory Transplant Module (PedsQL)
Time frame: Baseline, interval, and end of participation (Up to 18 years of age)
The Pediatric Quality of Life Inventory Transplant Module (PedsQL) is a 15 minute survey intended to measure emotional and physical function in children and determine state of wellbeing.
6 secondary outcomes
Transplant Rejection Rate Post Diabetes Diagnosis
Time frame: Up to three years
Rate of Vascular Disease Post Diabetes Diagnosis
Time frame: Up to three years
Mortality Rate Post Diabetes Diagnosis
Time frame: Up to three years
Change in the Wechsler Abbreviated Scale of Intelligence II (WASI-II) Score
Time frame: Baseline, interval, and end of participation (Up to 18 years)
Change in the Children Depression Inventory (CDI 2) Score
Time frame: Baseline, interval, and end of participation (Up to 18 years)
Change in the Behavior Assessment System for Children (BASC) Score
Time frame: Baseline, interval, and end of participation (Up to 18 years)
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 9 Dec 2020.
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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.
Nina Ham, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychologist Support and Pediatric Certified Diabetes Educators (CDEs) Support in people with Complications of Transplanted Organs and Tissue, run by Emory University at 2 sites 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 1 inclusion and 4 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 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 the Pediatric Quality of Life Inventory Transplant Module (PedsQL) (time frame: Baseline, interval, and end of participation (Up to 18 years of age)). 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 9 Dec 2020.