Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209196
Status:
COMPLETED
Last Update Posted:
2015-02-11
First Post:
2005-09-14
Brief Title:
Quality of Life in Pediatric Transplant Recipients
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Health Behaviors and Quality of Life in Pediatric Solid Organ Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Adherence to medical regimens refers to what degree a patient chooses to follow the advice given by hisher healthcare provider Good adherence typically involves behaviors such as the patient taking medication as directed and going to scheduled clinic appointments As many patients often do not follow the advice of doctors as closely as suggested many researchers have tried to find out the reasons behind patients being non-adherent This research has looked at medical conditions such as diabetes cystic fibrosis and asthma More recently researchers have started to look at adherence with children who have undergone solid organ transplantation This is because about 50 of these children are to some degree non-adherent with their medical regimen This comes at a costly price as ongoing non-adherence in pediatric transplant can lead to the childs body rejecting the new organ and even death This study has been designed to look at the reasons that pediatric patients may choose to be non-adherent This study will look at issues related to the patient eg age family support related to the disease and regimen eg length of illness how complicated the regimen is related to the medication eg taste side effects related to their mind eg memory problems confusion and related to their emotions eg being depressed anxious The investigators will be looking at each regimen-related behavior such as attending clinic appointments and will be asking each family about any barriers that make it difficult The investigators hope that knowing these barriers will help them make interventions that fit the specific issues that each patient faces Ultimately doctors transplant coordinators and psychological professionals will be able to use this information to intervene early with families who report barriers that impact adherence
Detailed Description:
This study will involve approximately 100 parents of pediatric patients who have received a solid organ transplant at Childrens Healthcare of Atlanta CHOA between January 1st 1988 and December 31st 2004 Within this sample pediatric patients who are 11-18 years of age will be invited to participate in a separate component of the project involving approximately 50 adolescents
ELIGIBILITY CRITERIA
For a parent to participate in this study the child must have had a solid organ transplant at CHOA patient is 5-18 years of age patient lives with the parents in the home and informed consent can be obtained For a child to participate in this study the child must have had a solid organ transplant at CHOA patient is 11-18 years of age patient lives with the parents in the home and informed assent can be obtained Family exclusionary criteria are as follows
patient has not lived with parent for at least 6 months
patients medical records are not accessible through the CHOA system
All participants will be referred by the respective transplant coordinator or one of the physicians in this study Parents will be provided with the findings upon request and referrals for psychological services will be made as necessary
RECRUITMENT
To recruit participants for the proposed study children and adolescents who received a solid organ transplant at CHOA between January 1st 1988 and December 31st 2004 will be identified by the transplant coordinators or physician for each solid organ Although multiple methods of recruitment will be used each family will only be contacted once
Clinic recruitment with the investigator present
Any patient family who is scheduled for an upcoming clinic visit will be approached by the transplant coordinator or other clinic-affiliated individual The investigation will be briefly described and interest in participating will be solicited
The parent will sign a letter of interest stating either
1 They are interested in learning more The form will also ask them to provide contact information home address and telephone number or
2 They are not interested and do not want to be contacted further
Only letters indicating interest will be given to investigators If a family signs the letter indicating interest an investigator present at clinic will approach the family to describe the investigation and obtain consentassent The family will have the option to
1 conduct the interview during the present clinic visit
2 schedule a future time to conduct the interview at the clinic or
3 conduct the interview via telephone
Clinic recruitment with the investigator not present
If an investigator is not present at the clinic the transplant coordinator or other clinic-affiliated individual will give the letters indicating interest to an investigator to contact the family via telephone to describe the study If after the telephone conversation a parent is interested in participating 2 copies of the consent form will be sent to the parents home with a self-addressed envelope to return one signed copy Following receipt of this form the parent will be contacted to schedule either
1 an interview at the clinic or
2 an interview via telephone
Mail recruitment
Any patient family who is not scheduled for an upcoming clinic visit will be contacted via mail from the transplant coordinator and transplant physician The letter will briefly describe the investigation and a letter of interest will be included Included will be a postage-paid envelope to return directly to the transplant team The transplant coordinator or other clinic-affiliated individual will give the letters indicating interest to an investigator to contact the family via telephone to describe the study If after the telephone conversation a parent would like to participate 2 copies of the consent form will be sent to the parents home with a self-addressed envelope to return one signed copy to the investigator Following receipt of this form the parent will be contacted to schedule either
1 an interview at the clinic or
2 an interview via telephone
Telephone recruitment
If a parent is not seen in the clinic and does not return a letter of interest the transplant coordinator or other clinic affiliated individual will call the family to briefly describe the investigation and obtain verbal consent for an investigator to contact them via telephone If they indicate that they are not interested in participating they will not be contacted further If a parent verbally consents to being contacted to learn more about the study an investigator will contact the family via telephone If after the telephone conversation a parent would like to participate 2 copies of the consent form will be sent to the parents home with a self-addressed envelope to return one signed copy to the investigator Following receipt of this form the parent will be contacted to schedule either
1 an interview at the clinic or
2 an interview via telephone
If the family is called three times with no success in reaching them this will be considered passive refusal and will not be contacted further
INTERVIEW PROCEDURE
The interview with each parent will consist of verbal consent and verbal administration of the PEDS-TX Survey Parent Version 10 the Medical Adherence Measure MAM the Child Health Questionnaire-Parent Form 50 CHQ-PF50 the SF-12 Health Survey SF-12 the Family Relationship Index FRI and demographic questions The interview with each participating adolescent patient will consist of verbal assent and the PEDS-TX Survey Adolescent Version 10 the Medical Adherence Measure MAM the Child Health Questionnaire-Child Form 80 CHQ-CF80 the Adolescent Risk Taking Survey ARTS and the Family Relationship Index FRI Each interview will be conducted by research assistants andor graduate students in psychology They will be trained in all research procedures by the principal investigator Training will include observed practice of procedures and skills taught focused on building rapport with and being sensitive to parents and patients with solid organ transplants verbally administering the assessment questionnaires in an accurate and comfortable manner giving answers to questions from parents and patients in an instructive manner that do not bias the research and lastly being culturally and socioeconomically sensitive when greeting and interviewing families
The data for this study will likely be obtained over a 6-9 month period with data from a specific parent and adolescent patient pair occurring within less than a week period ideally during the same phone call Each interview will last approximately 45-75 minutes
MEASURES
The measures for this investigation are as follows
Clinician Derived Measures
Medical Record Review
Prescription Refill records
Self-Report Measures
Demographic Information
PEDS-TX Survey Parent and Adolescent Version 10
Medical Adherence Measure
Child Health Questionnaire-Parent Form 50
SF-12 Health Survey
Family Relationship Index
Child Health Questionnaire-Child Form 80
Adolescent Risk Taking Survey
ELIGIBILITY CRITERIA
For a parent to participate in this study the child must have had a solid organ transplant at CHOA patient is 5-18 years of age patient lives with the parents in the home and informed consent can be obtained For a child to participate in this study the child must have had a solid organ transplant at CHOA patient is 11-18 years of age patient lives with the parents in the home and informed assent can be obtained Family exclusionary criteria are as follows
patient has not lived with parent for at least 6 months
patients medical records are not accessible through the CHOA system
All participants will be referred by the respective transplant coordinator or one of the physicians in this study Parents will be provided with the findings upon request and referrals for psychological services will be made as necessary
RECRUITMENT
To recruit participants for the proposed study children and adolescents who received a solid organ transplant at CHOA between January 1st 1988 and December 31st 2004 will be identified by the transplant coordinators or physician for each solid organ Although multiple methods of recruitment will be used each family will only be contacted once
Clinic recruitment with the investigator present
Any patient family who is scheduled for an upcoming clinic visit will be approached by the transplant coordinator or other clinic-affiliated individual The investigation will be briefly described and interest in participating will be solicited
The parent will sign a letter of interest stating either
1 They are interested in learning more The form will also ask them to provide contact information home address and telephone number or
2 They are not interested and do not want to be contacted further
Only letters indicating interest will be given to investigators If a family signs the letter indicating interest an investigator present at clinic will approach the family to describe the investigation and obtain consentassent The family will have the option to
1 conduct the interview during the present clinic visit
2 schedule a future time to conduct the interview at the clinic or
3 conduct the interview via telephone
Clinic recruitment with the investigator not present
If an investigator is not present at the clinic the transplant coordinator or other clinic-affiliated individual will give the letters indicating interest to an investigator to contact the family via telephone to describe the study If after the telephone conversation a parent is interested in participating 2 copies of the consent form will be sent to the parents home with a self-addressed envelope to return one signed copy Following receipt of this form the parent will be contacted to schedule either
1 an interview at the clinic or
2 an interview via telephone
Mail recruitment
Any patient family who is not scheduled for an upcoming clinic visit will be contacted via mail from the transplant coordinator and transplant physician The letter will briefly describe the investigation and a letter of interest will be included Included will be a postage-paid envelope to return directly to the transplant team The transplant coordinator or other clinic-affiliated individual will give the letters indicating interest to an investigator to contact the family via telephone to describe the study If after the telephone conversation a parent would like to participate 2 copies of the consent form will be sent to the parents home with a self-addressed envelope to return one signed copy to the investigator Following receipt of this form the parent will be contacted to schedule either
1 an interview at the clinic or
2 an interview via telephone
Telephone recruitment
If a parent is not seen in the clinic and does not return a letter of interest the transplant coordinator or other clinic affiliated individual will call the family to briefly describe the investigation and obtain verbal consent for an investigator to contact them via telephone If they indicate that they are not interested in participating they will not be contacted further If a parent verbally consents to being contacted to learn more about the study an investigator will contact the family via telephone If after the telephone conversation a parent would like to participate 2 copies of the consent form will be sent to the parents home with a self-addressed envelope to return one signed copy to the investigator Following receipt of this form the parent will be contacted to schedule either
1 an interview at the clinic or
2 an interview via telephone
If the family is called three times with no success in reaching them this will be considered passive refusal and will not be contacted further
INTERVIEW PROCEDURE
The interview with each parent will consist of verbal consent and verbal administration of the PEDS-TX Survey Parent Version 10 the Medical Adherence Measure MAM the Child Health Questionnaire-Parent Form 50 CHQ-PF50 the SF-12 Health Survey SF-12 the Family Relationship Index FRI and demographic questions The interview with each participating adolescent patient will consist of verbal assent and the PEDS-TX Survey Adolescent Version 10 the Medical Adherence Measure MAM the Child Health Questionnaire-Child Form 80 CHQ-CF80 the Adolescent Risk Taking Survey ARTS and the Family Relationship Index FRI Each interview will be conducted by research assistants andor graduate students in psychology They will be trained in all research procedures by the principal investigator Training will include observed practice of procedures and skills taught focused on building rapport with and being sensitive to parents and patients with solid organ transplants verbally administering the assessment questionnaires in an accurate and comfortable manner giving answers to questions from parents and patients in an instructive manner that do not bias the research and lastly being culturally and socioeconomically sensitive when greeting and interviewing families
The data for this study will likely be obtained over a 6-9 month period with data from a specific parent and adolescent patient pair occurring within less than a week period ideally during the same phone call Each interview will last approximately 45-75 minutes
MEASURES
The measures for this investigation are as follows
Clinician Derived Measures
Medical Record Review
Prescription Refill records
Self-Report Measures
Demographic Information
PEDS-TX Survey Parent and Adolescent Version 10
Medical Adherence Measure
Child Health Questionnaire-Parent Form 50
SF-12 Health Survey
Family Relationship Index
Child Health Questionnaire-Child Form 80
Adolescent Risk Taking Survey
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None