Improving Disease Knowledge in Adolescents With Sickle Cell Disease (KNOW-IT)

• ClinicalTrials.gov Identifier: NCT01945073
• Recruitment Status: Completed
• First Posted: September 18, 2013
• Last Update Posted: December 2, 2015
• Sponsor: The University of The West Indies
• Information provided by (Responsible Party): Monika Parshad-Asnani, The University of The West Indies

Tracking Information

• First Submitted Date: September 10, 2013
• First Posted Date: September 18, 2013
• Last Update Posted Date: December 2, 2015
• Study Start Date: August 2013
• Actual Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 2013)

Change in Disease Knowledge [ Time Frame: 3, 6 and 12 months ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 13, 2013)

• Change in Quality of Life [ Time Frame: 3, 6 and 12 months ]
• Change in Illness Perception [ Time Frame: 3, 6 and 12 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures (submitted: September 13, 2013): Predictors of change in knowledge [ Time Frame: 3, 6 and 12 months ]
• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Improving Disease Knowledge in Adolescents With Sickle Cell Disease
• Official Title: An Educational Intervention to Improve Disease Knowledge Among Adolescents With Sickle Cell Disease

Brief 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label)

Condition

• Sickle Cell Disease
• Quality of Life

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.

Study Arms

• No Intervention: Control (RC)
  Routine clinical care with no intervention
• Experimental: Educational Booklet (BK)
  Routine clinical care and educational booklet (BK) given
  Intervention: Behavioral: Educational Booklet (BK)
• Experimental: Educational Booklet and Counselling (CB)
  Routine clinical care, aided by formal counselling and active discussions from the educational booklet (CB)
  Interventions:

  • Behavioral: Educational Booklet (BK)
  • Other: Formal Counselling (CB)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 13, 2013): 150
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2015
• Actual Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years to 19 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Jamaica

Administrative Information

• NCT Number: NCT01945073
• Other Study ID Numbers: 0000
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Monika Parshad-Asnani, The University of The West Indies
• Original Responsible Party: Same as current
• Current Study Sponsor: The University of The West Indies
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Monika R Parshad-Asnani, MBBS MSc DM; Sickle Cell Unit, TMRI, UWI
• Study Director: Jennifer Knight-Madden, MBBS PhD; Sickle Cell Unit, TMRI, UWI

• PRS Account: The University of The West Indies
• Verification Date: November 2015