Psychological Concomitants of Morquio Syndrome (The MAP Study)
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Purpose
Mucopolysaccharidosis IV, also known as MPS IV or Morquio disease, is a rare autosomal recessive genetic lysosomal storage disorder. Research thus far regarding lysosomal storage diseases (LSDs) in general, including Morquio, has primarily focused on exploring the causes of and finding a treatment for the physical aspects of the various diseases. Less attention has been paid to the psychological or emotional toll of these diseases, whether they are direct symptoms of the diseases themselves or reactions to living with a chronic progressive disease.
It is well established in the health psychology literature, however, that the interaction between our physical health and our psychological health is bidirectional; that is, just as our physical health affects us emotionally (e.g. chronic pain can contribute to depression), so can our psychological health affect us physically (e.g. anxiety can contribute to feelings of chest pain). It is thus critically important to pay attention to the emotional and psychological symptoms associated with all lysosomal storage diseases, including Morquio, and expand our treatment standard of care to include mental health treatment, if necessary.
The first step in understanding and treating psychological conditions in Morquio disease is determining the natural occurrence of psychological symptoms in this population in comparison with non-medical populations. As little has been done in this regard, a pilot study documenting the occurrence rate of psychological issues and overall quality of life in patients with Morquio is the first item in order and will be the focus of this study.
Approximately 20 patients with Morquio disease will be invited to participate, recruited through Emory's Lysosomal Storage Disease Center, as well as through attendance at Morquio support groups and relevant regional, national and/or international meetings. Once consented, patients will be asked to complete three different self-report questionnaires, including the Achenbach System of Empirically Based Assessment (ASEBA) Adult Self-Report (ASR) or Older Adult Self-Report (OASR) questionnaire, the Short Form 36-item Health Questionnaire (SF-36), and the Brief Pain Inventory (BPI). Group aggregate data only will be reported; individual questionnaire content and results will be held confidential, except as in accordance with Georgia law relating to reporting of child or elder abuse, suicidal and/or homicidal intent. Completion of these questionnaires will complete subjects' participation in this pilot study.
| Condition |
|---|
|
Morquio Disease Mucopolysaccharidosis IV |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Psychological Concomitants of Morquio Syndrome |
- ASEBA Self-Report [ Time Frame: At enrollment, as a single-timepoint only ] [ Designated as safety issue: No ]Self-report questionnaire assessing psychological and adaptive functioning well-being
- Brief Pain Inventory [ Time Frame: At enrollment, as a single-timepoint only ] [ Designated as safety issue: No ]Self-report measure of subjective pain levels and interference of pain in daily functioning
- SF-36 [ Time Frame: At enrollment, as a single-timepoint only ] [ Designated as safety issue: No ]Brief self-report measure of quality of life
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
People with Morquio Disease
Inclusion Criteria:
- Documented clinical diagnosis of MPS IV based on clinical signs and symptoms of MPS IV and documented reduced fibroblast or leukocyte GALNS enzyme activity or genetic testing confirming diagnosis of MPS IV.
- Patient is at least 18 years old.
- Patient is not currently receiving enzyme replacement therapy for MPS IV.
- Patient must provide written, informed consent prior to study participation.
Exclusion Criteria:
- Previous treatment with ERT
- Previous hematopoietic stem-cell transplant
- Patient has a clinically significant disease (with the exception of symptoms of Morquio), including clinically significant immunologic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would confound the effects of Morquio upon study variables
Contacts and Locations| Contact: Nadia Ali, Ph.D. | 404-778-8613 | Nadia.Ali@emory.edu |
| Contact: Stephanie Cagle, MS, CGC | 404-778-8421 | Stephanie.Cagle@emoryhealthcare.org |
| United States, Georgia | |
| Emory University | Recruiting |
| Decatur, Georgia, United States, 30033 | |
| Contact: Nadia Ali, Ph.D. 404-778-8613 Nadia.Ali@emory.edu | |
| Contact: Stephanie Cagle, MS, CGC 404-778-8421 Stephanie.Cagle@emoryhealthcare.org | |
| Principal Investigator: Nadia Ali, Ph.D. | |
| Principal Investigator: | Nadia Ali, Ph.D. | Emory University |
More Information
No publications provided
| Responsible Party: | Nadia Ali, PhD, Health Psychologist / Instructor, Emory University |
| ClinicalTrials.gov Identifier: | NCT01752296 History of Changes |
| Other Study ID Numbers: | BioMarin-1 |
| Study First Received: | December 13, 2012 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Data and Safety Monitoring Board |
Keywords provided by Emory University:
|
Morquio Mucopolysaccharidosis IV Psychological health |
Additional relevant MeSH terms:
|
Mucopolysaccharidoses Mucopolysaccharidosis IV Osteochondrodysplasias Carbohydrate Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Lysosomal Storage Diseases |
Mucinoses Connective Tissue Diseases Metabolic Diseases Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013