Quality of Life in Parents of Adolescents With Spinal Deformities: Development of a New Questionnaire.

NCT04899297 | Active Not Recruiting

• 1 other identifier: PQOL-Isico
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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 ensure greater sensitivity and specificity of the questionnaire.

Conditions

Quality of Life; Spinal Deformity; Scoliosis; Adolescence

Keywords

Scoliosis; Quality of life; Spinal Deformity

Outcome Measures

Primary Outcomes (1)

• Parents' quality of life

  New questionnaire developped to assess quality of life of parents of patients with spinal deformity treated conservatively

  through study completion, an average of 1 year

Study Arms (1)

Quality of life

Other: Questionnaire

Interventions

Questionnaire OTHER

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.

Quality of life

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parents of adolescents with spinal deformities treated in a tertiary referral outpatient center.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Scientifico Italiano Colonna Vertebrale: lead

Study Sites (1)

ISICO

Milan, Mi, 20141, Italy

Location

MeSH Terms

Conditions

Scoliosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Fabio Zaina, MD

  Istituto Scientifico Italiano Colonna Vertebrale

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 24, 2021
• Study Start: May 7, 2021
• Primary Completion: April 8, 2024
• Study Completion: December 1, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)