Mother-caregivers of Children With Duchenne Muscular Dystrophy (DMDK)

Monica Levy Andersen

Status: Completed

Conditions: Other Diseases or Conditions

Treatments: Biological: Inflammatory profile; Biological: Hormonal profile; Biological: Cardiovascular profile; Biological: Metabolic profile; Biological: sleep parameters

Study type: Interventional

Funder types: Other

Identifiers

NCT01921374

DMDK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 5 patient groups

sleep parameters

Experimental group

Description:

To assess the sleep parameters.

Treatment:

Biological: sleep parameters

cardiovascular parameters

Other group

Description:

To assess the cardiovascular profile of control mothers and caregivers-mothers.

Treatment:

Biological: Cardiovascular profile

imflammatory and immunological profile

Experimental group

Description:

To assess the inflammatory profile of caregivers-mothers and control mothers

Treatment:

Biological: Inflammatory profile

hormonal profile

Experimental group

Description:

To assess the hormonal profile of caregivers-mothers and control mothers.

Treatment:

Biological: Hormonal profile

metabolic profile

Experimental group

Description:

To assess the health profile of caregivers-mothers and control mothers.

Treatment:

Biological: Metabolic profile