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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01945073
Recruitment Status : Completed
First Posted : September 18, 2013
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Monika Parshad-Asnani, The University of The West Indies

Study Description
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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.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Quality of Life Behavioral: Educational Booklet (BK) Other: Formal Counselling (CB) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: An Educational Intervention to Improve Disease Knowledge Among Adolescents With Sickle Cell Disease
Study Start Date : August 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Quality of Life [ Time Frame: 3, 6 and 12 months ]
  2. Change in Illness Perception [ Time Frame: 3, 6 and 12 months ]

Other Outcome Measures:
  1. Predictors of change in knowledge [ Time Frame: 3, 6 and 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945073


Locations
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Jamaica
Sickle Cell Unit, University of West Indies, Mona Campus
Kingston 7, Jamaica
Sponsors and Collaborators
The University of The West Indies
Investigators
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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
More Information
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Responsible Party: Monika Parshad-Asnani, Research Fellow, The University of The West Indies
ClinicalTrials.gov Identifier: NCT01945073    
Other Study ID Numbers: 0000
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Monika Parshad-Asnani, The University of The West Indies:
Educational intervention
Formal Counselling
Knowledge
Illness Perception
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn