Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03602378
Other study ID # 2181-198-03-04-18-0014
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date April 2, 2018
Est. completion date May 2, 2021

Study information

Verified date March 2020
Source University of Split, School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this cross-sectional study is to investigate the level of stress and quality of life in parents of children with developmental disabilities (Down syndrome, autism spectrum disorder, pervasive developmental disorder, cerebral palsy) and parents of children chronic diseases (diabetes mellitus type 1, epilepsy, asthma) compared to parents of healthy children.

The investigators will analyze the level of stress, quality of life, self-esteem, optimism, resilience, happiness, stigmatization, depression, anxiety, sleep quality, parenting challenges and some physiological indicators of the stress such as level of cortisol and heart rate variability. Also, the investigators will measure Advanced Glycation End products (AGEs) in the skin.

The investigators assume that parents of children with developmental disabilities and chronic diseases have higher level of stress and lower quality of life compared to the parents of healthy children.


Description:

Participants will be parents of children with a pervasive developmental disorder (autistic spectrum disorder), Down syndrome, cerebral palsy, epilepsy, diabetes mellitus type 1, asthma, and parents of healthy children (without difficulty and chronic disease - control group).

The investigators will examine the level of stress and quality of life in parents of children with developmental and chronic illnesses, compared to parents of healthy children, adjusting for the effect of confounding factors.

Data collection will be conducted using the questionnaire to assess personal quality of life, family quality of life, general and parental stress levels. Additionally, potential confounding or mediating factors will be measured and taken into account: stress resilience, cohesion, self-esteem, optimism, perception of happiness, stigmatization, depression, anxiety, sleep quality and parenting challenges. Also, socio-demographics parameters, short medical history, lifestyle habits and the perception of life difficulties will be assessed. The questionnaire will be filled by paper-pencil method with anticipated duration of about 45 minutes.

The investigators will also measure several physiological indicators - salivary cortisol, heart rate variability, blood pressure and Advanced Glycation End products (AGEs).

Saliva will be taken in order to analyze the cortisol level, using Salivette Sarstedt REF 51.1534.500. Participants will be taken five saliva samples during the day because of the physiological variability of cortisol (first one around 22:00 hours, second right after waking up, then 15, 30 and 60 minutes after awaking). Each subject will receive detailed instructions on how to take saliva, with written instructions. Thirty minutes before sampling, the subjects has to restrain from eating, drinking, smoking or brushing teeth. In case of acute illness, inflammation or disease in the oral cavity, the sampling will be delayed. After taking the sample, tubes will be stored in the refrigerator. In the laboratory, the sample will be centrifuged for two minutes to remove saliva from cotton, and saliva samples will be frozen. Cortisol analysis will be done using ECLIA (Electrochemiluminous Absorption Method).

The electrocardiogram (ECG) will be recorded using the Medilog AR12 Plus Holter device, which will also be used to record heart rate variability (HRV) during 5 minutes. HRV will also be recorded using the Polar V800 (also during 5 minutes). Kubios software will be used for HRV analysis.

AGE Reader, a non-invasive device will be used for measuring the autofluorescence in the skin, reflecting the level of Advanced Glycation End products (AGEs).

Omrom M6 Comfort is an automatic device which will be used to measure blood pressure and pulse.

Anthropometric parameters will be measured (body weight, height, neck circumference, waist and hip circumference).

Statistical analysis will be carried out using statistical program MedCalc. Initial analysis of results will include analysis of the distribution of variables using the Kolmogorov-Smirnov test. If the distribution of numerical variables will be normal, parametric statistics will be applied. The confounding factors will be controlled by using appropriate statistical tests.

Participation of parents in this study is voluntary. If a parent decides to participate in this study, the code will be assigned. In that way, all data, measured parameters, and saliva samples will be encoded, and the personal data of the respondents will be completely invisible. It will not be possible to identity an individual parent. All researchers must and will be protecting confidentiality of data.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 592
Est. completion date May 2, 2021
Est. primary completion date April 2, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- subject are parents between 20 and 50 years,

- subject are parents of the child with developmental disability (Down syndrome, autism spectrum disorder, pervasive developmental disorder, cerebral palsy) or chronic disease (diabetes mellitus type 1, epilepsy, asthma) - the ages of the child between 4 and 12 years.

Exclusion Criteria:

- severe psychiatry and severe chronic illnesses of parents

- ischemic heart disease

- cardiomyopathy

- heart arrhythmia

- malignant hypertension

- diabetic neuropathy

- transplantation of heart and other organs

- tetraplegia

- diseases of the hypothalamus and pituitary and adrenal gland

- corticosteroid therapy

- antiarrhythmic therapy

- therapy of ß-blockers

- therapy of sedatives

- therapy of anxiolytics

- chemotherapy

- night shift work

- breastfeeding (active or completed within less 6 months)

- pregnancy

- diagnose of child less than 6 months

- parents of children with other severe chronic or rare diseases such as malignant disease, haemophilia, phenylketonuria, neurofibromatosis.

Study Design


Intervention

Diagnostic Test:
salivary cortisol
5 samples of saliva (first sample before around 22:00 and other samples the next morning, after awakening (00, 15, 30 and 60 minutes).
Device:
Holter Medilog AR12 Plus
Holter Medilog AR12 Plus - electrocardiogram during 5 minutes for measuring HRV
Polar V800
Polar V800 with sensor - during 5 minutes for measuring HRV
AGE reader
for measuring Advanced Glycation End products (AGEs)

Locations

Country Name City State
Croatia Ivana Kolcic Split
Croatia University Hospital Split Split

Sponsors (2)

Lead Sponsor Collaborator
University of Split, School of Medicine General Hospital Zadar

Country where clinical trial is conducted

Croatia, 

References & Publications (69)

Ali BA, Abdelhakm AA, Abdelhameed MA, Tawfik NK. Quality of Life in Children with Type I Diabetes Mellitus (T1D) in Minia Governorate: Relationship with Mood and Family Attitudes. J Diabetes Metab 2017;8:5.

Andrade EM, Geha LM, Duran P, Suwwan R, Machado F, do Rosário MC. Quality of Life in Caregivers of ADHD Children and Diabetes Patients. Front Psychiatry. 2016 Jul 25;7:127. doi: 10.3389/fpsyt.2016.00127. eCollection 2016. — View Citation

Baba M, Ohkura M, Koga K, Nishiuchi K, Herrera LR, Matsuse R, Inoue T. Analysis of salivary cortisol levels to determine the association between depression level and differences in circadian rhythms of shift-working nurses. J Occup Health. 2015;57(3):237-44. doi: 10.1539/joh.14-0079-OA. Epub 2015 Mar 6. — View Citation

Bassett DR Jr. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1396. — View Citation

Bella GP, Garcia MC, Spadari-Bratfisch RC. Salivary cortisol, stress, and health in primary caregivers (mothers) of children with cerebral palsy. Psychoneuroendocrinology. 2011 Jul;36(6):834-42. doi: 10.1016/j.psyneuen.2010.11.005. Epub 2010 Dec 10. — View Citation

Berry JO, Jones WH. The parental stress scale: Initial psychometric evidence. Journal of Social and Personal Relationships 1995;12:463-72

Billman GE. Heart rate variability - a historical perspective. Front Physiol. 2011 Nov 29;2:86. doi: 10.3389/fphys.2011.00086. eCollection 2011. — View Citation

Bourke-Taylor H, Law M, Howie L, Pallant JF. Development of the Child's Challenging Behaviour Scale (CCBS) for mothers of school-aged children with disabilities. Child Care Health Dev. 2010 Jul;36(4):491-8. doi: 10.1111/j.1365-2214.2009.01055.x. Epub 2009 Dec 29. — View Citation

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. — View Citation

Chung F, Subramanyam R, Liao P, Sasaki E, Shapiro C, Sun Y. High STOP-Bang score indicates a high probability of obstructive sleep apnoea. Br J Anaesth. 2012 May;108(5):768-75. doi: 10.1093/bja/aes022. Epub 2012 Mar 8. — View Citation

Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation

Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. — View Citation

Crandal R. The measurement of self-esteem and related constructs, Pp. 80-82 in JP Robinson and PR Shaver (Eds), Measures of social psychological attitudes. Revised edition. Ann Arbor: ISR 1973.

Dardas LA, Ahmad MM. Quality of life among parents of children with autistic disorder: a sample from the Arab world. Res Dev Disabil. 2014 Feb;35(2):278-87. doi: 10.1016/j.ridd.2013.10.029. Epub 2013 Dec 4. — View Citation

de Vos LC, Lefrandt JD, Dullaart RP, Zeebregts CJ, Smit AJ. Advanced glycation end products: An emerging biomarker for adverse outcome in patients with peripheral artery disease. Atherosclerosis. 2016 Nov;254:291-299. doi: 10.1016/j.atherosclerosis.2016.10.012. Epub 2016 Oct 6. Review. — View Citation

Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. — View Citation

Eaves LC, Ho HH. The very early identification of autism: outcome to age 4 1/2-5. J Autism Dev Disord. 2004 Aug;34(4):367-78. — View Citation

El-Farhan N, Rees DA, Evans C. Measuring cortisol in serum, urine and saliva - are our assays good enough? Ann Clin Biochem. 2017 May;54(3):308-322. doi: 10.1177/0004563216687335. Epub 2017 Mar 16. Review. — View Citation

Epifanio MS, Genna V, Vitello MG, Roccella M, La Grutta S. Parenting stress and impact of illness in parents of children with coeliac disease. Pediatr Rep. 2013 Dec 19;5(4):e19. doi: 10.4081/pr.2013.e19. eCollection 2013. — View Citation

Foody C, James JE, Leader G. Parenting stress, salivary biomarkers, and ambulatory blood pressure: a comparison between mothers and fathers of children with autism spectrum disorders. J Autism Dev Disord. 2015 Apr;45(4):1084-95. doi: 10.1007/s10803-014-2263-y. — View Citation

Gagliano A, Lamberti M, Siracusano R, Ciuffo M, Boncoddo M, Maggio R, Rosina S, Cedro C, Germanò E. A Comparison between Children with ADHD and Children with Epilepsy in Self-Esteem and Parental Stress Level. Clin Pract Epidemiol Ment Health. 2014 Dec 24;10:176-83. doi: 10.2174/1745017901410010176. eCollection 2014. — View Citation

Giles D, Draper N, Neil W. Validity of the Polar V800 heart rate monitor to measure RR intervals at rest. Eur J Appl Physiol. 2016 Mar;116(3):563-71. doi: 10.1007/s00421-015-3303-9. Epub 2015 Dec 26. — View Citation

Gosling SD, Rentfrow PJ, Swann WB. A very brief measure of the Big-Five personality domains. Journal of Research in personality 2003;37:504-28.

Grover-Páez F, Cardona-Muñoz EG, Cardona-Müller D, Guzmán-Saldívar VH, Rodríguez-De la Cerda M, Jiménez-Cázarez MB, Totsuka-Sutto SE, Alanis-Sánchez GA, Ramos-Becerra CG. Validation of the Omron HEM-7320-LA, upper arm blood pressure monitor with Intelli Wrap Technology Cuff HEM-FL1 for self-measurement and clinic use according to the European Society of Hypertension International Protocol revision 2010 in the Mexican population. Blood Press Monit. 2017 Dec;22(6):375-378. doi: 10.1097/MBP.0000000000000290. — View Citation

Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. — View Citation

Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. — View Citation

Hodgson NA, Granger DA. Collecting saliva and measuring salivary cortisol and alpha-amylase in frail community residing older adults via family caregivers. J Vis Exp. 2013 Dec 18;(82):e50815. doi: 10.3791/50815. — View Citation

Hoffman L, Marquis J, Poston D, Summers JA, Turnbull A. Assessing Family Outcomes: Psychometric Evaluation of the Beach Center Family Quality of Life Scale. Journal of Marriage and Family 2006;68:1069-83.

Hofmann B, Jacobs K, Navarrete Santos A, Wienke A, Silber RE, Simm A. Relationship between cardiac tissue glycation and skin autofluorescence in patients with coronary artery disease. Diabetes Metab. 2015 Nov;41(5):410-5. doi: 10.1016/j.diabet.2014.12.001. Epub 2014 Dec 29. — View Citation

Hullmann SE, Wolfe-Christensen C, Ryan JL, Fedele DA, Rambo PL, Chaney JM, Mullins LL. Parental overprotection, perceived child vulnerability, and parenting stress: a cross-illness comparison. J Clin Psychol Med Settings. 2010 Dec;17(4):357-65. doi: 10.1007/s10880-010-9213-4. — View Citation

Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. — View Citation

Karhula K, Härmä M, Sallinen M, Lindholm H, Hirvonen A, Elovainio M, Kivimäki M, Vahtera J, Puttonen S. Salivary cortisol and alpha-amylase: Is there consistency between psychosocial stress test and burdensome work shifts? J Occup Environ Hyg. 2017 Dec;14(12):1003-1010. doi: 10.1080/15459624.2017.1350786. — View Citation

Kirschbaum C, Hellhammer DH. Salivary cortisol in psychoneuroendocrine research: recent developments and applications. Psychoneuroendocrinology. 1994;19(4):313-33. Review. — View Citation

Kleinman JM, Robins DL, Ventola PE, Pandey J, Boorstein HC, Esser EL, Wilson LB, Rosenthal MA, Sutera S, Verbalis AD, Barton M, Hodgson S, Green J, Dumont-Mathieu T, Volkmar F, Chawarska K, Klin A, Fein D. The modified checklist for autism in toddlers: a follow-up study investigating the early detection of autism spectrum disorders. J Autism Dev Disord. 2008 May;38(5):827-39. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. — View Citation

Leung C, Tsang SK. The Chinese Parental Stress Scale: psychometric evidence using Rasch modeling on clinical and nonclinical samples. J Pers Assess. 2010 Jan;92(1):26-34. doi: 10.1080/00223890903379209. — View Citation

Lupien SJ, Seguin F. How to measure stress in humans. Centre for Studies in Human Stress 2013.

Lyubomirsky S, Lepper HS. A measure of subjective happiness: Preliminary reliability and construct validation. Social indicators research 1999;46:137-55.

Mak WWS, Cheung RYM. Affiliate Stigma Among Caregivers of People with Intellectual Disability or Mental Illness. J Appl Res Intellect Disabil 2008;21:532-45.

Manee F, Ateya Y, Rassafiani M. A Comparison of the Quality of Life of Arab Mothers of Children with and without Chronic Disabilities. Phys Occup Ther Pediatr. 2016 Aug;36(3):260-71. doi: 10.3109/01942638.2015.1076558. Epub 2015 Nov 13. — View Citation

Monteagudo C, Mariscal-Arcas M, Rivas A, Lorenzo-Tovar ML, Tur JA, Olea-Serrano F. Proposal of a Mediterranean Diet Serving Score. PLoS One. 2015 Jun 2;10(6):e0128594. doi: 10.1371/journal.pone.0128594. eCollection 2015. — View Citation

Mugno D, Ruta L, D'Arrigo VG, Mazzone L. Impairment of quality of life in parents of children and adolescents with pervasive developmental disorder. Health Qual Life Outcomes. 2007 Apr 27;5:22. — View Citation

Niu SF, Chung MH, Chu H, Tsai JC, Lin CC, Liao YM, Ou KL, O'Brien AP, Chou KR. Differences in cortisol profiles and circadian adjustment time between nurses working night shifts and regular day shifts: A prospective longitudinal study. Int J Nurs Stud. 2015 Jul;52(7):1193-201. doi: 10.1016/j.ijnurstu.2015.04.001. Epub 2015 Apr 8. — View Citation

Norizan A, Shamsuddin K. Predictors of parenting stress among Malaysian mothers of children with Down syndrome. J Intellect Disabil Res. 2010 Nov;54(11):992-1003. doi: 10.1111/j.1365-2788.2010.01324.x. Epub 2010 Sep 27. — View Citation

Nunan D, Sandercock GR, Brodie DA. A quantitative systematic review of normal values for short-term heart rate variability in healthy adults. Pacing Clin Electrophysiol. 2010 Nov;33(11):1407-17. doi: 10.1111/j.1540-8159.2010.02841.x. Review. — View Citation

Orta OR, Gelaye B, Bain PA, Williams MA. The association between maternal cortisol and depression during pregnancy, a systematic review. Arch Womens Ment Health. 2018 Feb;21(1):43-53. doi: 10.1007/s00737-017-0777-y. Epub 2017 Sep 24. Review. — View Citation

Phillips BA, Conners F, Curtner-Smith ME. Parenting children with down syndrome: An analysis of parenting styles, parenting dimensions, and parental stress. Res Dev Disabil. 2017 Sep;68:9-19. doi: 10.1016/j.ridd.2017.06.010. Epub 2017 Jul 7. — View Citation

Poston D, Turnbull A, Park J, Mannan H, Marquis J, Wang M. Family quality of life: a qualitative inquiry. Ment Retard. 2003 Oct;41(5):313-28. — View Citation

Rogers SL, Hughes BA, Tomlinson JW, Blissett J. Cortisol metabolism, postnatal depression and weight changes in the first 12 months postpartum. Clin Endocrinol (Oxf). 2016 Dec;85(6):881-890. doi: 10.1111/cen.13150. Epub 2016 Aug 11. — View Citation

Roncada C, Dias CP, Goecks S, Cidade SE, Pitrez PM. [Usefulness of the WHOQOL-BREF questionnaire in assessing the quality of life of parents of children with asthma]. Rev Paul Pediatr. 2015 Jul-Sep;33(3):268-74. doi: 10.1016/j.rpped.2015.01.007. Epub 2015 Jun 9. Portuguese. — View Citation

Sammito S, Böckelmann I. Reference values for time- and frequency-domain heart rate variability measures. Heart Rhythm. 2016 Jun;13(6):1309-16. doi: 10.1016/j.hrthm.2016.02.006. Epub 2016 Feb 12. — View Citation

Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol. 1994 Dec;67(6):1063-78. — View Citation

Semakina NV, Mikhailov VA, Bagaev VI. Assessing the quality of life of families of children with epilepsy. Obozrenie psikhiatrii i meditsinskoi psikhologii im VM Bekhtereva 2012:73-6.

Simon CD, Adam EK, McKinney CO, Krohn JB, Shalowitz MU. Breastfeeding, Bed-Sharing, and Maternal Cortisol. Clin Pediatr (Phila). 2016 May;55(5):470-8. doi: 10.1177/0009922815601981. Epub 2015 Sep 1. — View Citation

Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

Stalder T, Kirschbaum C, Kudielka BM, Adam EK, Pruessner JC, Wüst S, Dockray S, Smyth N, Evans P, Hellhammer DH, Miller R, Wetherell MA, Lupien SJ, Clow A. Assessment of the cortisol awakening response: Expert consensus guidelines. Psychoneuroendocrinology. 2016 Jan;63:414-32. doi: 10.1016/j.psyneuen.2015.10.010. Epub 2015 Oct 20. Review. — View Citation

Stelmach-Mardas M, Iqbal K, Mardas M, Kostrzewska M, Piorunek T. Clinical Utility of Berlin Questionnaire in Comparison to Polysomnography in Patients with Obstructive Sleep Apnea. Adv Exp Med Biol. 2017;980:51-57. doi: 10.1007/5584_2017_7. — View Citation

Tarvainen MP, Niskanen JP, Lipponen JA, Ranta-Aho PO, Karjalainen PA. Kubios HRV--heart rate variability analysis software. Comput Methods Programs Biomed. 2014;113(1):210-20. doi: 10.1016/j.cmpb.2013.07.024. Epub 2013 Aug 6. — View Citation

Tolan PH, Gorman-Smith D, Huesmann LR, Zelli A. Assessment of family relationship characteristics: A measure to explain risk for antisocial behavior and depression among urban youth. Psychological Assessment 1997;9:212.

Tu MT, Lupien SJ, Walker CD. Diurnal salivary cortisol levels in postpartum mothers as a function of infant feeding choice and parity. Psychoneuroendocrinology. 2006 Aug;31(7):812-24. Epub 2006 May 23. — View Citation

Turner LM, Stone WL. Variability in outcome for children with an ASD diagnosis at age 2. J Child Psychol Psychiatry. 2007 Aug;48(8):793-802. — View Citation

Urfer-Maurer N, Ludyga S, Stalder T, Brand S, Holsboer-Trachsler E, Gerber M, Grob A, Weber P, Lemola S. Heart rate variability and salivary cortisol in very preterm children during school age. Psychoneuroendocrinology. 2018 Jan;87:27-34. doi: 10.1016/j.psyneuen.2017.10.004. Epub 2017 Oct 5. — View Citation

Vadakedom SS, Antony JM, Padma BK, Mammen DS, Thankappan BP. Quality of life of mothers of children with Down syndrome. J Evol Med Dent Sci-JEMDS 2017;6:2939-42.

Verberk WJ, Kessels AG, Thien T. Blood pressure measurement method and inter-arm differences: a meta-analysis. Am J Hypertens. 2011 Nov;24(11):1201-8. doi: 10.1038/ajh.2011.125. Epub 2011 Jul 21. — View Citation

Wolf JM, Miller GE, Chen E. Parent psychological states predict changes in inflammatory markers in children with asthma and healthy children. Brain Behav Immun. 2008 May;22(4):433-41. Epub 2007 Dec 18. — View Citation

Wolfram M, Bellingrath S, Kudielka BM. The cortisol awakening response (CAR) across the female menstrual cycle. Psychoneuroendocrinology. 2011 Jul;36(6):905-12. doi: 10.1016/j.psyneuen.2010.12.006. Epub 2011 Jan 14. — View Citation

Yaneva M, Mosnier-Pudar H, Dugué MA, Grabar S, Fulla Y, Bertagna X. Midnight salivary cortisol for the initial diagnosis of Cushing's syndrome of various causes. J Clin Endocrinol Metab. 2004 Jul;89(7):3345-51. — View Citation

* Note: There are 69 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life in parents of children with developmental disability and chronic disease, and healthy children. Subjects will complete the questionnaires about quality of life. A total 26 item in the WHOQOL-BREF produces four domain scores: physical, psychological, social relationships and environment domain (Likert type scale ranging from 1- strongly disagree to 5 - strongly agree). 1 day
Primary Stress in parents of children with developmental disability and chronic disease, and healthy children. Subjects will complete the questionnaires about parental stress. Parental Stress Scale consists of 18 item self report scale (Likert type scale ranging from 1-strongly disagree, 2-disagree, 3-undecided, 4-agree 5-strongly agree). Items represent positive (e.g. emotional benefits, personal development) and negative (demands on resources, restrictions) themes of parenthood. 1 days
Secondary Family quality of life A total 25 items in FQOL scale keyed for five domains scores: family interaction, parenting, emotional well-being, physical / material well-being and disability-related support (Likert type scale satisfaction are rated on a 5-point scale, where 1- very dissatisfied, 3-neither satisfied nor dissatisfied, and 5-very satisfied). Scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). 1 day
Secondary Perceived Stress Scale Perceived Stress Scale consists of 10 items (Likert type scale ranging from 0-never, 1-almost never, 2-sometimes,3-fairly often, 4-very often). Higher scores indicating greater levels of stress. 1 day
Secondary Salivary cortisol concentration in parents of children with developmental disability, chronic disease and parents of healthy children. 5 samples of saliva (first sample before around 22:00 and other samples the next morning, after awakening (00, 15, 30 and 60 minutes)). 1 day
Secondary Heart rate variability in parents of children with developmental disability, chronic disease and parents of healthy children Holter Medilog AR12 Plus - electrocardiogram and Polar V800 with sensor - during 5 minutes 1 day
Secondary Advanced glycation end products in parents of children with developmental disability, chronic disease and parents of healthy children. AGE reader for measuring advanced glycation end products. Higher results indicating greater cardiovascular risk. 1 day
See also
  Status Clinical Trial Phase
Completed NCT04624425 - Additional Effects of Segmental Breathing In Asthma N/A
Terminated NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma Phase 2
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT03694158 - Investigating Dupilumab's Effect in Asthma by Genotype Phase 4
Terminated NCT04946318 - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma Phase 2
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Completed NCT03086460 - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH) Phase 2
Completed NCT01160224 - Oral GW766944 (Oral CCR3 Antagonist) Phase 2
Completed NCT03186209 - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) Phase 3
Completed NCT02502734 - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma Phase 3
Completed NCT01715844 - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics Phase 1
Terminated NCT04993443 - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Phase 1
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT06033833 - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Phase 2
Completed NCT03257995 - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. Phase 2
Completed NCT02212483 - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT01468805 - Childhood Asthma Reduction Study N/A
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device