Clinical trial NCT01921374: Mother-caregivers of Children With Duchenne Muscular Dystrophy
Official title: Profile of Mother-caregivers of Children With Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Diseases or Conditions
Keywords: Duchenne;
mothers caregivers;
sleep;
hormonal profile;
cardiac profile;
biochemical profile;
inflammatory profile.
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2013-08-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: sleep patterns of the study population
timeFrame: Baseline
Secondary outcomes:
measure: Hormonal profile
timeFrame: Baseline
measure: Inflammatory profile
timeFrame: Baseline
measure: Cardiovascular profile
timeFrame: Baseline
measure: Metabolic profile
timeFrame: Baseline
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University Federal of São Paulo
Study officials:
References:
citation: 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.
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. doi: 10.1111/j.1532-5415.1992.tb01986.x.
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.