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

Primary Purpose

Other Diseases or Conditions

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
sleep parameters
Hormonal profile
Inflammatory profile
Cardiovascular profile
Metabolic profile
Sponsored by
Monica Levy Andersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Other Diseases or Conditions focused on measuring Duchenne;, mothers caregivers;, sleep;, hormonal profile;, cardiac profile;, biochemical profile;, inflammatory profile.

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • University Federal of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Other

Experimental

Experimental

Experimental

Arm Label

sleep parameters

cardiovascular parameters

imflammatory and immunological profile

hormonal profile

metabolic profile

Arm Description

To assess the sleep parameters.

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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 1β Interleukin 2 Interleukin 4 Interleukin 8 Interferon-gamma (IFN-γ) Endothelin Prostaglandin E2 Intercellular Adhesion Molecule 1 (ICAM) Vascular cell adhesion protein 1 (VCAM) Tumor necrosis factor (TNFα) Adiponectin Leptin Cysteine Lymphocytes subpopulations (T e B)
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)
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

Full Information

First Posted
August 8, 2013
Last Updated
February 2, 2016
Sponsor
Monica Levy Andersen
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1. Study Identification

Unique Protocol Identification Number
NCT01921374
Brief Title
Mother-caregivers of Children With Duchenne Muscular Dystrophy
Acronym
DMDK
Official Title
Profile of Mother-caregivers of Children With Duchenne Muscular Dystrophy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Monica Levy Andersen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Diseases or Conditions
Keywords
Duchenne;, mothers caregivers;, sleep;, hormonal profile;, cardiac profile;, biochemical profile;, inflammatory profile.

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sleep parameters
Arm Type
Experimental
Arm Description
To assess the sleep parameters.
Arm Title
cardiovascular parameters
Arm Type
Other
Arm Description
To assess the cardiovascular profile of control mothers and caregivers-mothers.
Arm Title
imflammatory and immunological profile
Arm Type
Experimental
Arm Description
To assess the inflammatory profile of caregivers-mothers and control mothers
Arm Title
hormonal profile
Arm Type
Experimental
Arm Description
To assess the hormonal profile of caregivers-mothers and control mothers.
Arm Title
metabolic profile
Arm Type
Experimental
Arm Description
To assess the health profile of caregivers-mothers and control mothers.
Intervention Type
Biological
Intervention Name(s)
sleep parameters
Intervention Description
Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.
Intervention Type
Biological
Intervention Name(s)
Hormonal profile
Other Intervention Name(s)
Insulin, Cortisol, Luteinizing hormone (LH), Follicle-stimulating hormone (FSH), Total Testosterone, Estradiol, Progesterone, Vitamin B12, Adrenocorticotropic hormone (ACTH)
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Inflammatory profile
Other Intervention Name(s)
C-reactive protein (PCR), Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Complement (C3), Complement (C4), Interleukin 6, Interleukin 10, Interleukin 1β, Interleukin 2, Interleukin 4, Interleukin 8, Interferon-gamma (IFN-γ), Endothelin, Prostaglandin E2, Intercellular Adhesion Molecule 1 (ICAM), Vascular cell adhesion protein 1 (VCAM), Tumor necrosis factor (TNFα), Adiponectin, Leptin, Cysteine, Lymphocytes subpopulations (T e B)
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Cardiovascular profile
Other Intervention Name(s)
Homocysteine, Myoglobin, Cardiac troponin I, Creatine kinase (CK), Creatine kinase MB (CKMB)
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Metabolic profile
Other Intervention Name(s)
Glucose, Total cholesterol and fractions, Triglycerides, Uric acid, Creatinine, Urea, Sodium, Potassium, Hemogram, Erythrocyte sedimentation rate, Natriuretic Peptide B
Intervention Description
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
Primary Outcome Measure Information:
Title
sleep patterns of the study population
Description
Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Hormonal profile
Description
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)
Time Frame
Baseline
Title
Inflammatory profile
Description
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 1β Interleukin 2 Interleukin 4 Interleukin 8 Interferon-gamma (IFN-γ) Endothelin Prostaglandin E2 Intercellular Adhesion Molecule 1 (ICAM) Vascular cell adhesion protein 1 (VCAM) Tumor necrosis factor (TNFα) Adiponectin Leptin Cysteine Lymphocytes subpopulations (T e B)
Time Frame
Baseline
Title
Cardiovascular profile
Description
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)
Time Frame
Baseline
Title
Metabolic profile
Description
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
Time Frame
Baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University Federal of São Paulo
City
São Paulo
ZIP/Postal Code
04024001
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
19160150
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.
Results Reference
background
PubMed Identifier
1512385
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.
Results Reference
background
PubMed Identifier
22008789
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.
Results Reference
background
Links:
URL
http://www.sleepresearchsociety.org/
Description
Sleep research society

Learn more about this trial

Mother-caregivers of Children With Duchenne Muscular Dystrophy

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