Mother-caregivers of Children With Duchenne Muscular Dystrophy

Other Diseases or Conditions Clinical Trial

— DMDK  

Official title:

Profile of Mother-caregivers of Children With Duchenne Muscular Dystrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921374
• Other study ID #: DMDK
• Status: Completed
• Phase: N/A
• First received: August 8, 2013
• Last updated: February 2, 2016
• Start date: August 2013
• Est. completion date: July 2014

Study information

• Verified date: February 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministério da Saúde and Ethical Committee of Federal University of Sao Paulo.
• Study type: Interventional

Clinical Trial Summary

The incidence of Duchenne Muscular Dystrophy (DMD) is approximately 1 in 3.500 male newborns. During its progression there is loss of mobility, swallowing difficulties and a significant reduction in respiratory capacity. Due to the severity and consequences, is inevitable the need for a caregiver, that normally rely the mother.

Description:

The Duchenne Muscular Dystrophy (DMD) is a neuromuscular disease characterized by genetic alteration, whose consequence is the progression of muscle degeneration. The mother-caregiver dedicates herself entirely to her son, putting aside the care of their physical and psychological health. The responsibility and workload to care for the child is high. Because of this extreme amount of work associated with other factors such as stress, this mothers-caregivers are more likely to develop hypertension, respiratory disease, susceptibility to infections, depression, anxiety, insomnia, impaired immune and cardiovascular problems. Moreover, they are more likely to develop sleep disorders, those who may cause a high health risk, since many sleep disorders are related to cardiovascular, respiratory, neurological and immune systems.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Mothers-caregivers of children and adolescents with DMD

• Mothers of children and adolescents without any neuromuscular disease and that does not have any chronic disease (bronchiolitis obliterates, cystic fibrosis, a genetic syndrome)

Exclusion Criteria:

• Volunteers with low levels of education (voluntary functional illiterate) that prevents the questionnaires and understanding of the guidelines made

• Working mothers of nocturnal period

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Other Diseases or Conditions

Intervention

Biological:
• sleep parameters
Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.
• Hormonal profile
To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters.
• Inflammatory profile
To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters
• Cardiovascular profile
To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters
• Metabolic profile
To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters

Locations

Country	Name	City	State
Brazil	University Federal of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Monica Levy Andersen

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Donders J, Taneja C. Neurobehavioral characteristics of children with Duchenne muscular dystrophy. Child Neuropsychol. 2009 May;15(3):295-304. doi: 10.1080/09297040802665777. Epub 2009 Jan 22. — View Citation

Draper BM, Poulos CJ, Cole AM, Poulos RG, Ehrlich F. A comparison of caregivers for elderly stroke and dementia victims. J Am Geriatr Soc. 1992 Sep;40(9):896-901. — View Citation

Fee RJ, Hinton VJ. Resilience in children diagnosed with a chronic neuromuscular disorder. J Dev Behav Pediatr. 2011 Nov;32(9):644-50. doi: 10.1097/DBP.0b013e318235d614. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep patterns of the study population	Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.	Baseline	Yes
Secondary	Hormonal profile	To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters: Insulin Cortisol Luteinizing hormone (LH) Follicle-stimulating hormone (FSH) Total Testosterone Estradiol Progesterone Vitamin B12 Adrenocorticotropic hormone (ACTH)	Baseline	Yes
Secondary	Inflammatory profile	To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters: C-reactive protein (PCR) Immunoglobulin A (IgA) Immunoglobulin G (IgG) Immunoglobulin M (IgM) Complement (C3) Complement (C4) Interleukin 6 Interleukin 10 Interleukin 1ß Interleukin 2 Interleukin 4 Interleukin 8 Interferon-gamma (IFN-?) Endothelin Prostaglandin E2 Intercellular Adhesion Molecule 1 (ICAM) Vascular cell adhesion protein 1 (VCAM) Tumor necrosis factor (TNFa) Adiponectin Leptin Cysteine Lymphocytes subpopulations (T e B)	Baseline	Yes
Secondary	Cardiovascular profile	To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters: Homocysteine Myoglobin Cardiac troponin I Creatine kinase (CK) Creatine kinase MB (CKMB)	Baseline	Yes
Secondary	Metabolic profile	To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters: Glucose Total cholesterol and fractions Triglycerides Uric acid Creatinine Urea Sodium Potassium Hemogram Erythrocyte sedimentation rate Natriuretic Peptide B	Baseline	Yes

External Links

•   Site about Neuromuscular diseases
•   Sleep research society