Improving Disease Knowledge in Adolescents With Sickle Cell Disease

Quality of Life Clinical Trial

— KNOW-IT  

Official title:

An Educational Intervention to Improve Disease Knowledge Among Adolescents With Sickle Cell Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945073
• Other study ID #: 0000
• Status: Completed
• Phase: N/A
• First received: September 10, 2013
• Last updated: November 30, 2015
• Start date: August 2013
• Est. completion date: April 2015

Study information

• Verified date: November 2015
• Source: The University of The West Indies
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jamaica: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Increased knowledge about an illness can increase self-management among those afflicted. In order to facilitate people with sickle cell disease living a longer and healthier life, they should be taught to manage their illness.An adolescent with a chronic illness has many unique challenges, in addition to maneuvering the turbulent adolescence period itself. It has been that better knowledge and more positive perceptions of their illness equate not only to better control of their illness but also better quality of life.Studies have also shown the benefits of self-management: when patients are responsible for managing their own illness, their clinical outcomes and quality of life improve and they become less dependent on health care services.

In this study we aim to examine if knowledge, and any changes in knowledge, will each have any association with Quality of Life (QOL) and their perceptions of their illness (IP). We also seek to investigate the effects of an educational booklet, as well as an intervention including the educational booklet with formal counselling on their knowledge, QOL and IPs.

Description:

In this inquiry, we wish to apply an educational intervention to determine if there are any improvements in disease knowledge as a result among adolescents attending the Sickle Cell Unit (SCU) in Jamaica. We also wish to examine if knowledge, and any changes in knowledge, will each have any association with Quality of Life (QOL) and their perceptions of their illness (IP).

Our specific hypotheses are:

1. Important predictors of knowledge among adolescents with Sickle Cell Disease (SCD) are gender, age, education of the adolescent as well as of the parents, socioeconomic status, frequency of attendance at SCU, rural/urban residence, and disease severity.

2. The intervention involving training using an educational booklet specific to 'teens living with SCD' will improve knowledge among the adolescents

3. Adding 'individual Counselling' to the intervention will increase the benefits

4. Improvements in knowledge will translate to improvements in QOL and positive IPs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 19 Years

Eligibility

Inclusion Criteria:

• All adolescent patients, ages 13-19 years inclusive, with Sickle Cell Disease that attend the Sickle Cell Unit at University of the West Indies, Mona Campus will be eligible for the study and hence will be asked to participate.

Exclusion Criteria:

• adolescent with neurological disorders e.g. Cerebrovascular accidents or with physical or intellectual disabilities will be excluded.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Quality of Life
• Sickle Cell Disease

Intervention

Behavioral:
• Educational Booklet (BK)
The information booklet provides age appropriate explanation about SCD: inheritance patterns for the trait and common sickle cell disorders in the Jamaican population. It includes manifestations, complications and the necessary preventive and treatment advice. In addition, issues that are common to adolescents including sexual activity, contraceptive use, drug usage, career advice and developmental changes common to persons with the disease are also discussed.

Other:
• Formal Counselling (CB)
The study coordinator will have a face to face counselling session, lasting about 30 minutes, with the adolescent and/or caregiver. This will include the use of the educational booklet as an education tool, as well as a thorough discussion on the disease process; its manifestations, effects, and specific concerns during the adolescent period; as well as clarification of common myths and misconceptions about the disease.

Locations

Country	Name	City	State
Jamaica	Sickle Cell Unit, University of West Indies, Mona Campus	Kingston 7

Sponsors (1)

Lead Sponsor	Collaborator
The University of The West Indies

Country where clinical trial is conducted

Jamaica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Predictors of change in knowledge		3, 6 and 12 months	No
Primary	Change in Disease Knowledge	In this inquiry, we wish to apply an educational intervention to determine if there are any improvements in disease knowledge as a result among adolescents attending the Sickle Cell Unit in Jamaica. We also wish to examine if knowledge, and any changes in knowledge, will each have any association with Quality of Life and their perceptions of their illness.	3, 6 and 12 months	No
Secondary	Change in Quality of Life		3, 6 and 12 months	No
Secondary	Change in Illness Perception		3, 6 and 12 months	No