NCT01945073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 10, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

1.7 years

First QC Date

September 10, 2013

Last Update Submit

November 30, 2015

Conditions

Keywords

Educational interventionFormal CounsellingKnowledgeIllness Perception

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Change in Quality of Life

    3, 6 and 12 months

  • Change in Illness Perception

    3, 6 and 12 months

Other Outcomes (1)

  • Predictors of change in knowledge

    3, 6 and 12 months

Study Arms (3)

Control (RC)

NO INTERVENTION

Routine clinical care with no intervention

Educational Booklet (BK)

EXPERIMENTAL

Routine clinical care and educational booklet (BK) given

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)

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

Interventions

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.

Educational Booklet (BK)Educational Booklet and 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.

Educational Booklet and Counselling (CB)

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sickle Cell Unit, University of West Indies, Mona Campus

Kingston, Jamaica

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Monika R Parshad-Asnani, MBBS MSc DM

    Sickle Cell Unit, TMRI, UWI

    PRINCIPAL INVESTIGATOR
  • Jennifer Knight-Madden, MBBS PhD

    Sickle Cell Unit, TMRI, UWI

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 18, 2013

Study Start

August 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations