Quality of LifeNCT04899297
Quality of Life in Parents of Adolescents With Spinal Deformities: Development of a New Questionnaire.
An observational study of Quality of Life and Spinal Deformity, run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
Trial summary
This study aims to develop a new instrument capable of providing an efficient measure of the quality of life of parents of conservatively treated patients with spinal deformity. The development of a questionnaire in a Rasch environment and specifically developed for parents of conservatively treated patients will… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Spinal Deformity, Scoliosis; Adolescence
- What is being tested?
- Questionnaire
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 7 May 2021to Dec 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parents of adolescents with spinal deformities treated in a tertiary referral outpatient center.
Who may be able to join
- have at least one child between the ages of 10 and 18 with adolescent idiopathic scoliosis of 10 degrees or more, or with Scheuermann's kyphosis or idiopathic hyperkyphosis
- prescription of a brace or specific exercises for the child's vertebral deformity.
Who cannot join
- Child with a history of spinal surgery
- Child with a history of significant diseases with possible impact on the quality of life of the parents
- Child with a history of spinal trauma
- Child with positive neurological evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life in Parents of Conservatively Treated Adolescents With Spinal Deformities: Development of a New Questionnaire.
This study aims to develop a new instrument capable of providing an efficient measure of the quality of life of parents of conservatively treated patients with spinal deformity. The development of a questionnaire in a Rasch environment and specifically developed for parents of conservatively treated patients will ensure greater sensitivity and specificity of the questionnaire.
- Conditions
- Quality of Life, Spinal Deformity, Scoliosis; Adolescence
- Being tested
- Questionnaire
- Keywords
- Scoliosis, Quality of life, Spinal Deformity
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
All parents of patients visited at an outpatient service dedicated to the treatment of vertebral deformities will be recruited at the end of the medical clinical evaluation. The doctor will invite all subjects to complete the questionnaire anonymously at the end of each follow-up visit.
| Study group | Role | What they receive |
|---|---|---|
| Quality of life | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents' quality of life
New questionnaire developped to assess quality of life of parents of patients with spinal deformity treated conservatively
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start7 May 2021
- Primary completion8 Apr 2024
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Scientifico Italiano Colonna Vertebrale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Zaina, MD, Principal investigator, Istituto Scientifico Italiano Colonna Vertebrale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899297
- Sponsor's protocol ID
- PQOL-Isico
- Status last verified
- May 2024
- First submitted
- 6 May 2021
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Parents of Conservatively Treated Adolescents With Spinal Deformities: Development of a New Questionnaire.
- ClinicalTrials.gov ID
- NCT04899297
- Acronym / sponsor ID
- PQOL-Isico
- Conditions
- Quality of Life, Spinal Deformity, Scoliosis; Adolescence
- Keywords
- Scoliosis, Quality of life, Spinal Deformity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Istituto Scientifico Italiano Colonna VertebraleUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 May 2021 (actual)
- 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.
This study aims to develop a new instrument capable of providing an efficient measure of the quality of life of parents of conservatively treated patients with spinal deformity. The development of a questionnaire in a Rasch environment and specifically developed for parents of conservatively treated patients will ensure greater sensitivity and specificity of the questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of life | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parents of adolescents with spinal deformities treated in a tertiary referral outpatient center.
Key inclusion criteria (2 listed)
- have at least one child between the ages of 10 and 18 with adolescent idiopathic scoliosis of 10 degrees or more, or with Scheuermann's kyphosis or idiopathic hyperkyphosis
- prescription of a brace or specific exercises for the child's vertebral deformity.
Key exclusion criteria (4 listed)
- Child with a history of spinal surgery
- Child with a history of significant diseases with possible impact on the quality of life of the parents
- Child with a history of spinal trauma
- Child with positive neurological evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAll parents of patients visited at an outpatient service dedicated to the treatment of vertebral deformities will be recruited at the end of the medical clinical evaluation. The doctor will invite all subjects to complete the questionnaire anonymously at the end of each follow-up visit. | Other | Quality of life |
Primary outcome
Parents' quality of life
Time frame: through study completion, an average of 1 year
New questionnaire developped to assess quality of life of parents of patients with spinal deformity treated conservatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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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.
Fabio Zaina, MD principal investigator
Istituto Scientifico Italiano Colonna Vertebrale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Spinal Deformity, run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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.
What does the primary outcome measure?
Parents' quality of life (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024.