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
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