Health Challenges for Adolescents With Chronic Diseases in Egypt

NCT05207449 | Unknown

• 1 other identifier: PhD2021
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The World Health Organization (WHO) defines adolescents as those people between 10 and 19 years of age. Adolescence is a critical developmental stage especially in the context of living with a chronic disease (CD), a chronic disease can be defined as "physiological, behavioral or cognitive disorder that has lasted for one year and produces one or more types of consequences: functional constraints, dependency on compensatory assistance for functioning, or increased need of service compared with age-mates". The burden of chronic conditions in adolescence is increasing as larger numbers of chronically ill children survive beyond the age of 10. Over 85% of children with congenital or chronic conditions now survive into adolescence, and conditions once seen only in young children are now seen beyond childhood and adolescence.

Conditions

Adolescent Behavior; Chronic Disease; Adherence, Medication; Quality of Life

Outcome Measures

Primary Outcomes (4)

• Percentage of adolescents with chronic conditions showing good adherence to treatment as measured by Medication Adherence Report Scale (MARS)

  3- Assessment of adherence to treatment by using Arabic validated version of Medication Adherence Report Scale (MARS): 5- items rated on a 5-point scale. The cut point used for the MARS score will be ≥80% (i.e. if the score ¬≥ 20 the adolescent will be considered adherent)

  6 months

• percentage of adolescents with chronic disease showing high acceptance to thier chronic disease measured by Acceptance to Illness Scale (AIS)

  5- Disease acceptance will be evaluated using: Arabic validated version of Acceptance to Illness Scale (AIS) (42) which consists of 8- items rated on a 5-point scale, where (1 means strongly agree; 2-agree; 3-undecided; 4-disagree; 5-strongly disagree) . The total score of the scale ranges from 8 to 40; the higher score, the better acceptance of illness.

  6 months

• percentage of adolescents with chronic disease showing high quality of life measured by Arabic version of the Pediatric Qualify of Life Inventory Generic Core Scale

  6- Assessment of health-related quality of life (HRQoL) using the Arabic version of the Pediatric Qualify of Life Inventory Generic Core Scale (PedsQL) 4.0 GCS (43): It is a 23-item which includes: 1. Physical Functioning (8 items). 2. Emotional Functioning (5 items). 3. Social Functioning (5 items). 4. School Functioning (5 items). The response options of the PedsQL (4.0) require children to rate each item using a 5-point rating scale ranging from 'never' to 'almost always' as follow: * 0 if it is never a problem. * 1 if it is almost never a problem. * 2 if it is sometimes a problem. * 3 if it is often a problem. * 4 if it is almost always a problem Each item was then reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0, so that higher scores indicate a better HRQoL

  6 months

• Percentage of adolescents with chronic disease showing high readiness for transition to adult health care setting measured by The Transition Readiness Assessment Questionnaire (TRAQ)

  7- Assessment of readiness for transition to adult health care settings using The Transition Readiness Assessment Questionnaire (TRAQ), which is a validated 20-item, 5-domain (appointment keeping- tracking health issues- managing medications-taking with providers-managing daily activities) patient-reported assessment of health and health care self-management skills that can be used in preparation for transition to adult care

  6 months

Interventions

Questionnaire OTHER

The questionnaire will include: 1. The demographic data of the patients 2. Chronic disease related questions 3. Assessment of adherence to treatment by using Arabic validated version of Medication Adherence Report Scale (MARS) 4. Patients' beliefs about medication will be assessed using Arabic validated version of Beliefs about Medicines Questionnaire (BMQ) 5. Disease acceptance will be evaluated using: Arabic validated version of Acceptance to Illness Scale (AIS) 6. Assessment of health-related quality of life (HRQoL) using the Arabic version of the Pediatric Qualify of Life Inventory Generic Core Scale (PedsQL) 4.0 GCS 7. Assessment of readiness for transition to adult health care settings using The Transition Readiness Assessment Questionnaire (TRAQ)

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Adolescents with different chronic disease (such as: DM-1, thalassemia, rheumatoid arthritis, systemic lupus and chronic kidney disease, etc..) attending different pediatric outpatient clinics and inpatient units at Assiut University Pediatric Hospital and Sidi Galal Health Insurance Clinic.

You may qualify if:

• Any adolescent aged 10-18 years having chronic disease for more than one year with regular medications prescriptions

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Adolescent Behavior; Chronic Disease; Medication Adherence

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

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 Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: January 26, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: January 26, 2022

Record last verified: 2022-01