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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03218033
Other study ID # 038689EP
Secondary ID
Status Completed
Phase N/A
First received July 5, 2017
Last updated July 12, 2017
Start date May 1, 2014
Est. completion date January 31, 2015

Study information

Verified date July 2017
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study was to examine the effect of an online educational program with and without a social media experience.The primary goal of this study was to determine whether medication adherence would be improved by having adolescents and young adults with systemic lupus erythematosus participate in an online educational website, with or without a social media experience. The secondary goal was to determine whether secondary outcomes such as quality of life, stress, and self-efficacy improved in this model, and whether these changes were associated with improvements in medication management.


Description:

Self-management skills, including medication management, are vital to the health of adolescents and young adults with systemic lupus erythematosus (SLE). Non-adherence with medications in patients with systemic lupus has been noted to be as poor as 40%. Success in disease control can be significantly impacted by such non-adherence. Poor medication compliance is associated with higher SLE disease activity scores and higher SLE disease activity in turn has been demonstrated to be significantly associated with a decline in quality of life. Much attention has been paid to how to improve self-management skills in adults, but less is known about how to target adolescents, an age group with a complex set of emotional and developmental needs.

The goal of this study was to examine the effect of an online educational program with and without a social media experience.The primary goal of this study was to determine whether medication adherence would be improved by having adolescents and young adults with SLE participate in an online educational website, with or without a social media experience. The secondary goal was to determine whether secondary outcomes such as quality of life, stress, and self-efficacy improved in this model, and whether these changes were associated with improvements in medication management.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date January 31, 2015
Est. primary completion date January 31, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 23 Years
Eligibility Inclusion Criteria:

- age between 13 and 23 at the time of recruitment

- having the diagnosis of SLE made or confirmed by a pediatric or adult rheumatologist at Penn State Children's Hospital/Hershey Medical Center

- having regular internet access.

Exclusion Criteria:

- age <13 or >23 years

- comorbid medical or psychiatric illness that would affect the outcome measures.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Social Media


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Milton S. Hershey Medical Center Children's Miracle Network, Lupus Foundation of America

Outcome

Type Measure Description Time frame Safety issue
Primary Medication Adherence A medication possession ratio was calculated based on fill date information from the subjects' pharmacies 6 months
Secondary Stress utilizing the Perceived Severity of Stress Questionnaire Stress was measured by the Perceived Severity of Stress Questionnaire (PSQ) 14 weeks
Secondary Self-efficacy utilizing the Children's Arthritis Self-Efficacy scale Self-efficacy was measured using the Children's Arthritis Self-Efficacy scale (CASE) which was modified slightly for systemic lupus 14 weeks
Secondary Quality of Life utilizing the Simple Measure of the Impact of Lupus Erythematosus in Youngsters (SMILEY) index Quality of life was assessed using the validated Simple Measure of the Impact of Lupus Erythematosus in Youngsters (SMILEY) index 14 weeks
Secondary Sense of agency Sense of agency (SOA) was measured via three Likert scale questions aimed to tap three core concepts of agency: competence ("Blogging… makes me feel I have control over my own voice"), assertiveness ("…enables me to assert myself"), and confidence ("…makes me feel I have a distinct voice") 14 weeks
Secondary Sense of community Sense of community (SOC) was measured using a 22-item scale (8, 9, 20). SOC consists of feelings of belonging to the community, having influence on, and being influenced by, the community, being supported by the community while also supporting them; and feelings of shared emotional connection. 14 weeks
Secondary Empowerment Empowerment was assessed using a validated quantitative Likert scale tool that measured 1) "empowering processes" (Appendix A), and 2) "empowering outcomes" 14 weeks
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