Sickle Cell DiseaseKNOW-ITNCT01945073
Improving Disease Knowledge in Adolescents With Sickle Cell Disease
A study testing Educational Booklet (BK) and Formal Counselling (CB) in people with Sickle Cell Disease and Quality of Life, run by The University of The West Indies at 1 site in Jamaica.
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… Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Sickle Cell Disease, Quality of Life
- What is being tested?
- Educational Booklet (BK) and Formal Counselling (CB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteJamaica
- Study dates
- Aug 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- adolescent with neurological disorders e.g. Cerebrovascular accidents or with physical or intellectual disabilities will be excluded.
Trial locations and contacts
1 site in 1 country.
Jamaica1 site
Sickle Cell Unit, University of West Indies, Mona Campus
Kingston
About this study
Official title: An Educational Intervention to Improve Disease Knowledge Among Adolescents With Sickle Cell Disease
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.
Read the 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:
- 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.
- The intervention involving training using an educational booklet specific to 'teens living with SCD' will improve knowledge among the adolescents
- Adding 'individual Counselling' to the intervention will increase the benefits
- Improvements in knowledge will translate to improvements in QOL and positive IPs.
- Conditions
- Sickle Cell Disease, Quality of Life
- Being tested
- Educational Booklet (BK), Formal Counselling (CB)
- Keywords
- Educational intervention, Formal Counselling, Knowledge, Illness Perception
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Booklet (BK)Behavioural
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.
Formal Counselling (CB)Other
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 group | Role | What they receive |
|---|---|---|
| Control (RC) | No intervention | Routine clinical care with no intervention |
| Educational Booklet (BK) | Experimental | Routine clinical care and educational booklet (BK) given Receives: Behavioral: Educational Booklet (BK) |
| Educational Booklet and Counselling (CB) | Experimental | Routine clinical care, aided by formal counselling and active discussions from the educational booklet (CB) Receives: Behavioral: Educational Booklet (BK); Other: Formal Counselling (CB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3, 6 and 12 months
Secondary outcomes (2)
Change in Quality of Life
Measured: 3, 6 and 12 months
Change in Illness Perception
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monika Parshad-Asnani, The University of The West Indies
- Investigators
- Monika R Parshad-Asnani, MBBS MSc DM, Principal investigator, Sickle Cell Unit, TMRI, UWIJennifer Knight-Madden, MBBS PhD, Study director, Sickle Cell Unit, TMRI, UWI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945073
- Sponsor's protocol ID
- 0000
- Acronym
- KNOW-IT
- Status last verified
- Nov 2015
- First submitted
- 10 Sep 2013
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Educational Intervention to Improve Disease Knowledge Among Adolescents With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT01945073
- Acronym / sponsor ID
- KNOW-IT / 0000
- Conditions
- Sickle Cell Disease, Quality of Life
- Keywords
- Educational intervention, Formal Counselling, Knowledge, Illness Perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 18 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- The intervention involving training using an educational booklet specific to 'teens living with SCD' will improve knowledge among the adolescents
- Adding 'individual Counselling' to the intervention will increase the benefits
- Improvements in knowledge will translate to improvements in QOL and positive IPs.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control (RC) | No intervention | –Routine clinical care with no intervention |
| Educational Booklet (BK) | Experimental | Behavioral: Educational Booklet (BK)Routine clinical care and educational booklet (BK) given |
| Educational Booklet and Counselling (CB) | Experimental | Behavioral: Educational Booklet (BK), Other: Formal Counselling (CB)Routine clinical care, aided by formal counselling and active discussions from the educational booklet (CB) |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- adolescent with neurological disorders e.g. Cerebrovascular accidents or with physical or intellectual disabilities will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Educational Booklet (BK), Educational Booklet and Counselling (CB) |
| 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. | Other | Educational Booklet and Counselling (CB) |
Primary outcome
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.
2 secondary outcomes
Change in Quality of Life
Time frame: 3, 6 and 12 months
Change in Illness Perception
Time frame: 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika R Parshad-Asnani, MBBS MSc DM principal investigator
Sickle Cell Unit, TMRI, UWI
Jennifer Knight-Madden, MBBS PhD study director
Sickle Cell Unit, TMRI, UWI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Booklet (BK) and Formal Counselling (CB) in people with Sickle Cell Disease and Quality of Life, run by The University of The West Indies at 1 site in Jamaica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disease Knowledge (time frame: 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.