AsthmaNCT00005461
Epidemiology of Symptom Perception in Childhood Asthma
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To investigate the determinants of valid symptom perception in childhood asthma and the relation of symptom perception to asthma morbidity. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Asthma, Lung Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1991to Jun 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To investigate the determinants of valid symptom perception in childhood asthma and the relation of symptom perception to asthma morbidity.
Read the detailed description
BACKGROUND:
The treatment of childhood asthma increasingly entails self-management as an important factor in influencing the course of the disease. The study identified subgroups of children who were at increased risk of misinterpreting, and thus mismanaging, their pulmonary function. Identification of the characteristics of these high risk children formed the basis for subsequent development of an intervention program to improve symptom self-perception, thereby enhancing the children's ability to participate effectively in self-management of their asthma.
DESIGN NARRATIVE:
The specific hypotheses tested in the cross-sectional prevalence study were: 1) greater validity of self-perceived symptoms was associated with less functional morbidity from asthma; 2) specific psychological and asthma-related determinants affected the sensitivity and specificity of symptom perception in children with asthma; 3) perception of respiratory symptoms was a measurable characteristic that could be evaluated in terms of reliability and validity; 4) perceptual accuracy in a natural or clinical setting was significantly related to perceptual ability measured in a laboratory.
Investigation of these objectives used a study of validity of self-perception of symptoms in relation to clinical status. Children aged 8-15 made subjective estimates of their asthma severity immediately prior to pulmonary function testing at multiple times while they lived either at a summer camp for children with asthma or a long-term asthma treatment center. The correspondence between subjective and objective measures of pulmonary function in the clinical environment were compared with results obtained in a laboratory using threshold detection of added resistive loads. The sensitivity and specificity of asthmatic children's self-assessment of symptom state were quantified and related retrospectively to risk of functional morbidity. Cognitive abilities, anxiety level, tendency toward repression, locus of control, and familial factors were investigated regarding their role as determinants of sensitivity and specificity of symptom self-perception as a measure of pulmonary function. The stability of individual patterns of self-perception were studied longitudinally with annual repeated evaluations among those children who returned to camp or were rehospitalized.
The study with its three-component research plan was renewed in fiscal year 1997. Component 1 strengthened understanding of the psychologic and physiologic correlates of perceptual ability. A positive association was expected between perceptual accuracy and a) intelligence; b) attention; c) symptom focus; d) systemic steroid use; and e) predominantly large airway or mixed airway involvement. Component 2 explored the relationship between chemosensitivity and resistive-load perception in high risk pediatric asthma patients. It was hypothesized that, compared to other asthmatics and controls, adolescents who had near fatal asthma attacks a) had higher thresholds for detecting resistive loads; b) had a decreased response to progressive isocapneic hypoxia; and c) had a smaller increase in respiratory drive during progressive hypercapnia. Component 3 characterized the family and self-management patterns moderating variables between perception and morbidity. It was hypothesized that a) symptom perception interacted with family asthma management in relation to asthma morbidity b) poor symptom perception was associated with worse medication compliance; and c) better family functioning was related to better perception and lower functional morbidity. Methodologic approaches included a naturalistic clinical accuracy protocol; laboratory studies using a computerized resistive-loading apparatus to determine perceptual thresholds; a chemosensitivity protocol investigating drive; family assessment interviews, and computerized metered dose inhaler technology to assess compliance with asthma medications.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Asthma, Lung Diseases
- Medical subject headings
- Asthma, Lung Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startApr 1991
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Gregory Fritz, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005461
- Sponsor's protocol ID
- 4905
- Other IDs
- R01HL045157
- Status last verified
- Jul 2004
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Fritz GK, Yeung A, Wamboldt MZ, Spirito A, McQuaid EL, Klein R, Seifer R. Conceptual and methodologic issues in quantifying perceptual accuracy in childhood asthma. J Pediatr Psychol. 1996 Apr;21(2):153-73. doi: 10.1093/jpepsy/21.2.153.
PubMed 8920151Fritz GK, McQuaid EL, Spirito A, Klein RB. Symptom perception in pediatric asthma: relationship to functional morbidity and psychological factors. J Am Acad Child Adolesc Psychiatry. 1996 Aug;35(8):1033-41. doi: 10.1097/00004583-199608000-00014.
PubMed 8755800Klein RB, Fritz GK, Yeung A, McQuaid EL, Mansell A. Spirometric patterns in childhood asthma: peak flow compared with other indices. Pediatr Pulmonol. 1995 Dec;20(6):372-9. doi: 10.1002/ppul.1950200607.
PubMed 8649917Fritz G, Spirito A, Yeung A, Klein R, Freedman E. A pictorial visual analog scale for rating severity of childhood asthma episodes. J Asthma. 1994;31(6):473-8. doi: 10.3109/02770909409089489.
PubMed 7961324Fritz GK, Yeung A, Taitel MS. Symptom perception and self-management in childhood asthma. Curr Opin Pediatr. 1994 Aug;6(4):423-7. doi: 10.1097/00008480-199408000-00012.
PubMed 7951663Fritz GK, McQuaid EL, Nassau JH, Klein RB, Mansell A. Thresholds of resistive load detection in children with asthma. Pediatr Pulmonol. 1999 Oct;28(4):271-6. doi: 10.1002/(sici)1099-0496(199910)28:43.0.co;2-c.
PubMed 10497376Gavin LA, Wamboldt MZ, Sorokin N, Levy SY, Wamboldt FS. Treatment alliance and its association with family functioning, adherence, and medical outcome in adolescents with severe, chronic asthma. J Pediatr Psychol. 1999 Aug;24(4):355-65. doi: 10.1093/jpepsy/24.4.355.
PubMed 10431501Frankel K, Wamboldt MZ. Chronic childhood illness and maternal mental health--why should we care? J Asthma. 1998;35(8):621-30. doi: 10.3109/02770909809048964.
PubMed 9860082Wamboldt MZ, Schmitz S, Mrazek D. Genetic association between atopy and behavioral symptoms in middle childhood. J Child Psychol Psychiatry. 1998 Oct;39(7):1007-16.
PubMed 9804033Wamboldt MZ, Fritz G, Mansell A, McQuaid EL, Klein RB. Relationship of asthma severity and psychological problems in children. J Am Acad Child Adolesc Psychiatry. 1998 Sep;37(9):943-50. doi: 10.1097/00004583-199809000-00014.
PubMed 9735613Wamboldt MZ, Yancey AG Jr, Roesler TA. Cardiovascular effects of tricyclic antidepressants in childhood asthma: a case series and review. J Child Adolesc Psychopharmacol. 1997 Spring;7(1):45-64. doi: 10.1089/cap.1997.7.45.
PubMed 9192541Bender B, Wamboldt FS, O'Connor SL, Rand C, Szefler S, Milgrom H, Wamboldt MZ. Measurement of children's asthma medication adherence by self report, mother report, canister weight, and Doser CT. Ann Allergy Asthma Immunol. 2000 Nov;85(5):416-21. doi: 10.1016/s1081-1206(10)62557-4.
PubMed 11101187Wamboldt FS, O'Connor SL, Wamboldt MZ, Gavin LA, Klinnert MD. The five minute speech sample in children with asthma: deconstructing the construct of expressed emotion. J Child Psychol Psychiatry. 2000 Oct;41(7):887-98.
PubMed 11079431Gabriels RL, Wamboldt MZ, McCormick DR, Adams TL, McTaggart SR. Children's illness drawings and asthma symptom awareness. J Asthma. 2000;37(7):565-74. doi: 10.3109/02770900009090811.
PubMed 11059523Wamboldt MZ, Wamboldt FS. Role of the family in the onset and outcome of childhood disorders: selected research findings. J Am Acad Child Adolesc Psychiatry. 2000 Oct;39(10):1212-9. doi: 10.1097/00004583-200010000-00006.
PubMed 11026173
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Symptom Perception in Childhood Asthma
- ClinicalTrials.gov ID
- NCT00005461
- Acronym / sponsor ID
- 4905
- Conditions
- Asthma, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1991
- Study completion
- Jun 2002 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the determinants of valid symptom perception in childhood asthma and the relation of symptom perception to asthma morbidity.
Detailed description
BACKGROUND:
The treatment of childhood asthma increasingly entails self-management as an important factor in influencing the course of the disease. The study identified subgroups of children who were at increased risk of misinterpreting, and thus mismanaging, their pulmonary function. Identification of the characteristics of these high risk children formed the basis for subsequent development of an intervention program to improve symptom self-perception, thereby enhancing the children's ability to participate effectively in self-management of their asthma.
DESIGN NARRATIVE:
The specific hypotheses tested in the cross-sectional prevalence study were: 1) greater validity of self-perceived symptoms was associated with less functional morbidity from asthma; 2) specific psychological and asthma-related determinants affected the sensitivity and specificity of symptom perception in children with asthma; 3) perception of respiratory symptoms was a measurable characteristic that could be evaluated in terms of reliability and validity; 4) perceptual accuracy in a natural or clinical setting was significantly related to perceptual ability measured in a laboratory.
Investigation of these objectives used a study of validity of self-perception of symptoms in relation to clinical status. Children aged 8-15 made subjective estimates of their asthma severity immediately prior to pulmonary function testing at multiple times while they lived either at a summer camp for children with asthma or a long-term asthma treatment center. The correspondence between subjective and objective measures of pulmonary function in the clinical environment were compared with results obtained in a laboratory using threshold detection of added resistive loads. The sensitivity and specificity of asthmatic children's self-assessment of symptom state were quantified and related retrospectively to risk of functional morbidity. Cognitive abilities, anxiety level, tendency toward repression, locus of control, and familial factors were investigated regarding their role as determinants of sensitivity and specificity of symptom self-perception as a measure of pulmonary function. The stability of individual patterns of self-perception were studied longitudinally with annual repeated evaluations among those children who returned to camp or were rehospitalized.
The study with its three-component research plan was renewed in fiscal year 1997. Component 1 strengthened understanding of the psychologic and physiologic correlates of perceptual ability. A positive association was expected between perceptual accuracy and a) intelligence; b) attention; c) symptom focus; d) systemic steroid use; and e) predominantly large airway or mixed airway involvement. Component 2 explored the relationship between chemosensitivity and resistive-load perception in high risk pediatric asthma patients. It was hypothesized that, compared to other asthmatics and controls, adolescents who had near fatal asthma attacks a) had higher thresholds for detecting resistive loads; b) had a decreased response to progressive isocapneic hypoxia; and c) had a smaller increase in respiratory drive during progressive hypercapnia. Component 3 characterized the family and self-management patterns moderating variables between perception and morbidity. It was hypothesized that a) symptom perception interacted with family asthma management in relation to asthma morbidity b) poor symptom perception was associated with worse medication compliance; and c) better family functioning was related to better perception and lower functional morbidity. Methodologic approaches included a naturalistic clinical accuracy protocol; laboratory studies using a computerized resistive-loading apparatus to determine perceptual thresholds; a chemosensitivity protocol investigating drive; family assessment interviews, and computerized metered dose inhaler technology to assess compliance with asthma medications.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 8920151Fritz GK, Yeung A, Wamboldt MZ, Spirito A, McQuaid EL, Klein R, Seifer R. Conceptual and methodologic issues in quantifying perceptual accuracy in childhood asthma. J Pediatr Psychol. 1996 Apr;21(2):153-73. doi: 10.1093/jpepsy/21.2.153.
- Background: PubMed 8755800Fritz GK, McQuaid EL, Spirito A, Klein RB. Symptom perception in pediatric asthma: relationship to functional morbidity and psychological factors. J Am Acad Child Adolesc Psychiatry. 1996 Aug;35(8):1033-41. doi: 10.1097/00004583-199608000-00014.
- Background: PubMed 8649917Klein RB, Fritz GK, Yeung A, McQuaid EL, Mansell A. Spirometric patterns in childhood asthma: peak flow compared with other indices. Pediatr Pulmonol. 1995 Dec;20(6):372-9. doi: 10.1002/ppul.1950200607.
- Background: PubMed 7961324Fritz G, Spirito A, Yeung A, Klein R, Freedman E. A pictorial visual analog scale for rating severity of childhood asthma episodes. J Asthma. 1994;31(6):473-8. doi: 10.3109/02770909409089489.
- Background: PubMed 7951663Fritz GK, Yeung A, Taitel MS. Symptom perception and self-management in childhood asthma. Curr Opin Pediatr. 1994 Aug;6(4):423-7. doi: 10.1097/00008480-199408000-00012.
- Background: PubMed 10497376Fritz GK, McQuaid EL, Nassau JH, Klein RB, Mansell A. Thresholds of resistive load detection in children with asthma. Pediatr Pulmonol. 1999 Oct;28(4):271-6. doi: 10.1002/(sici)1099-0496(199910)28:43.0.co;2-c.
- Background: PubMed 10431501Gavin LA, Wamboldt MZ, Sorokin N, Levy SY, Wamboldt FS. Treatment alliance and its association with family functioning, adherence, and medical outcome in adolescents with severe, chronic asthma. J Pediatr Psychol. 1999 Aug;24(4):355-65. doi: 10.1093/jpepsy/24.4.355.
- Background: PubMed 9860082Frankel K, Wamboldt MZ. Chronic childhood illness and maternal mental health--why should we care? J Asthma. 1998;35(8):621-30. doi: 10.3109/02770909809048964.
- Background: PubMed 9804033Wamboldt MZ, Schmitz S, Mrazek D. Genetic association between atopy and behavioral symptoms in middle childhood. J Child Psychol Psychiatry. 1998 Oct;39(7):1007-16.
- Background: PubMed 9735613Wamboldt MZ, Fritz G, Mansell A, McQuaid EL, Klein RB. Relationship of asthma severity and psychological problems in children. J Am Acad Child Adolesc Psychiatry. 1998 Sep;37(9):943-50. doi: 10.1097/00004583-199809000-00014.
- Background: PubMed 9192541Wamboldt MZ, Yancey AG Jr, Roesler TA. Cardiovascular effects of tricyclic antidepressants in childhood asthma: a case series and review. J Child Adolesc Psychopharmacol. 1997 Spring;7(1):45-64. doi: 10.1089/cap.1997.7.45.
- Background: PubMed 11101187Bender B, Wamboldt FS, O'Connor SL, Rand C, Szefler S, Milgrom H, Wamboldt MZ. Measurement of children's asthma medication adherence by self report, mother report, canister weight, and Doser CT. Ann Allergy Asthma Immunol. 2000 Nov;85(5):416-21. doi: 10.1016/s1081-1206(10)62557-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Fritz
Rhode Island Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005461, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.