Posttraumatic Stress Disorder Clinical Trial
— FSS-QLSOfficial title:
Freeman-Sheldon Syndrome Quality of Life Study (FSS-QLS): Cross-sectional Study of Concomitant Disorder-Specific Contributors to Quality of Life and Clinical Outcome
Verified date | April 2017 |
Source | Freeman-Sheldon Research Group, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Freeman-Sheldon syndrome (FSS) is a rare human neuromusculoskeletal disorder present before
birth, involving primarily limb and craniofacial deformities.
The hypotheses in the present study of FSS and related conditions are: (1) FSS and related
conditions are associated with higher rates of posttraumatic stress symptoms (PTSS),
depression, and reduced quality of life than is observed in the general population; (2)
persons close to an individual with FSS or related condition suffer similarly; and (3)
current measures, which are single-disease specific (i.e., PTSS, depression, craniofacial
deformities, or limb deformities), do not capture the unique picture of FSS and related
conditions, which involve both limb and craniofacial deformities in an intellectually
capable individual.
There have been no studies looking at quality of life associated with FSS. Some authors have
looked at quality of life in persons with facial differences; other authors have looked at
bone and joint problems. Many other authors have looked at PTSS and depression caused by
health problems and bad medical experiences. No authors have looked at these problems when
they happen together, as they do in FSS. Because of the above, there may be differences in
patients that have FSS versus patients in previous quality of life studies. The study will
also develop and validate an outcomes-based quality of life survey for FSS and related
conditions.
Status | Terminated |
Enrollment | 6 |
Est. completion date | April 1, 2017 |
Est. primary completion date | April 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Freeman-Sheldon syndrome, - Sheldon-Hall syndrome, - Distal arthrogryposis type 1, or - distal arthrogryposis type 3 - Deceased probands with enough clinical information available to satisfy study requirements - Probands who participated in a prior Freeman-Sheldon Research Group (FSRG)-study are automatically accepted, since their diagnoses have been confirmed by FSRG clinical faculty. - Probands with a reported qualifying diagnosis, who have not participated in a prior FSRG-study, will be required to complete the complete a survey from a prior study and provide photographs and any requested medical records to confirm their diagnoses. - Family members and other close contacts may enrol, so long as they have either resided with or had substantial and prolonged contact with a proband, who has an FSRG-verified qualifying diagnosis. Investigators will make the final decision on a case-by-case basis, based on information provided. Exclusion Criteria: - Patients with other anomalies, not having one of the above syndromes, will not be accepted. - Deceased probands will not be accepted for analysis, without enough clinical data available to satisfy study data collection requirements. - Patients or parents of minor children not willing to give consent will not be included. - Family members or other contacts that neither resided with nor had substantial and prolonged contact with the proband. |
Country | Name | City | State |
---|---|---|---|
Guatemala | San Juan de Dios General Hospital | Guatemala City | |
United States | Freeman-Sheldon Research Group, Inc. Headquarters | Buckhannon | West Virginia |
Lead Sponsor | Collaborator |
---|---|
Freeman-Sheldon Research Group, Inc. |
United States, Guatemala,
Apajasalo M, Sintonen H, Rautonen J, Kaitila I. Health-related quality of life of patients with genetic skeletal dysplasias. Eur J Pediatr. 1998 Feb;157(2):114-21. — View Citation
Chamberlain RL, Poling MI, Portillo AL, Morales A, Ramirez RR, McCormick RJ. Freeman-Sheldon syndrome in a 29-year-old woman presenting with rare and previously undescribed features. BMJ Case Rep. 2015 Oct 22;2015. pii: bcr2015212607. doi: 10.1136/bcr-201 — View Citation
Didierjean-Pillet A. [Psychological approach to congenital hand deformities. Congenital deformities, the desire to know]. Ann Chir Plast Esthet. 2002 Feb;47(1):2-8. French. — View Citation
Hawkins SS, Radcliffe J. Current measures of PTSD for children and adolescents. J Pediatr Psychol. 2006 May;31(4):420-30. Epub 2005 Jun 9. Review. — View Citation
McCormick RJ, Poling MI, Chamberlain RL. Bilateral patellar tendon-bearing Symes-type prostheses in a severe case of Freeman-Sheldon syndrome in a 21-year-old woman presenting with uncorrectable equinovarus. BMJ Case Rep. 2015 Jul 15;2015. pii: bcr2015211 — View Citation
McCormick RJ, Poling MI, Portillo AL, Chamberlain RL. Preliminary experience with delayed non-operative therapy of multiple hand and wrist contractures in a woman with Freeman-Sheldon syndrome, at ages 24 and 28 years. BMJ Case Rep. 2015 Jul 14;2015. pii: — View Citation
Nagata S, Funakosi S, Amae S, Yoshida S, Ambo H, Kudo A, Yokota A, Ueno T, Matsuoka H, Hayashi Y. Posttraumatic stress disorder in mothers of children who have undergone surgery for congenital disease at a pediatric surgery department. J Pediatr Surg. 2008 Aug;43(8):1480-6. doi: 10.1016/j.jpedsurg.2007.12.055. — View Citation
Poling MI, Dufresne CR, Chamberlain RL. Dr Ben Franklin and an unusual modern-day cure for recurrent pleuritis. Br J Gen Pract. 2017 Jan;67(654):32-33. doi: 10.3399/bjgp17X688705. — View Citation
Poling MI, Morales Corado JA, Chamberlain RL. Findings, phenotypes, and outcomes in Freeman-Sheldon and Sheldon-Hall syndromes and distal arthrogryposis types 1 and 3: protocol for systematic review and patient-level data meta-analysis. Syst Rev. 2017 Mar — View Citation
Roye BD, Vitale MG, Gelijns AC, Roye DP Jr. Patient-based outcomes after clubfoot surgery. J Pediatr Orthop. 2001 Jan-Feb;21(1):42-9. — View Citation
Vitale MG, Choe JC, Vitale MA, Lee FY, Hyman JE, Roye DP Jr. Patient-based outcomes following clubfoot surgery: a 16-year follow-up study. J Pediatr Orthop. 2005 Jul-Aug;25(4):533-8. — View Citation
Vitale MG, Levy DE, Johnson MG, Gelijns AC, Moskowitz AJ, Roye BP, Verdisco L, Roye DP Jr. Assessment of quality of life in adolescent patients with orthopaedic problems: are adult measures appropriate? J Pediatr Orthop. 2001 Sep-Oct;21(5):622-8. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Situational Mental Health in Persons with FSS or Related Condition | Increased frequency of mental health symptoms and diagnoses (PTSS, Depression, and reduced quality of life) over expected for general population | Evaluated during 1-2 study visits (lasting an average of 1-3 hours each) and in self-completed surveys, over an average of 2-4 years from enrolment | |
Secondary | Situational Mental Health in Family and Others with a Close Relationship to a Person with FSS or Related Condition | Increased frequency of mental health symptoms and diagnoses (PTSS, Depression, and reduced quality of life) over expected for general population | Evaluated during 1-2 study visits (lasting an average of 1-3 hours each) and in self-completed surveys, over an average of 2-4 years from enrolment | |
Secondary | Current Survey Correlation with Disorder-Specific Survey for FSS and Related Conditions | Ability of current surveys to capture full picture of quality of life for persons, families, and others affected by FSS and related conditions will be assessed to determine need for a disorder-specific survey and usefulness of existing surveys. | Evaluated during 1-2 study visits (lasting an average of 1-3 hours each) and in self-completed surveys, over an average of 2-4 years from enrolment |
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