Systemic LupusNCT03218033
Use of Social Media to Improve Medication Adherence in Adolescents and Young Adults With Systemic Lupus
A study testing Social Media in people with Systemic Lupus, run by Milton S. Hershey Medical Center.
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… Read more about this study
- Who is it for?
- Ages 13 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus
- What is being tested?
- Social Media
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2014to 31 Jan 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 23 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- age <13 or >23 years
- comorbid medical or psychiatric illness that would affect the outcome measures.
About this study
Official title: Improvement of Medication Adherence in Adolescents With SLE Using Web-based Education With and Without a Social Media Intervention
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.
Read the detailed 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.
- Conditions
- Systemic Lupus
- Being tested
- Social Media
- Keywords
- systemic lupus, self-management, social media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social MediaBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants visited the Facinglupustogether.com website and participated in consecutive weekly modules for 8 weeks. At the end of each module there were questions pertaining to the subject of each module. The control group answered the questions in provided journals and these were sent back to the investigator. All subjects completed surveys in REDCap prior to the study intervention and again 6 weeks after study completion to assess secondary outcome measures. Medication adherence was assessed by calculating a medication possession ratio by acquiring information on fill dates at the subjects' pharmacies. |
| Social Media (SM) | Active comparator | The intervention phase was 8 weeks in duration. Participants visited the Facinglupustogether.com website and participated in consecutive weekly modules. 8 The SM group answered the questions at the end of each module on a blogging site with other SM participants. SM participants were encouraged to provide feedback or questions about the material or personal questions that arose in response to each module.
All subjects completed surveys in REDCap prior to the study intervention and again 6 weeks after study completion to assess secondary outcome measures. Medication adherence was assessed by calculating a medication possession ratio by acquiring information on fill dates at the subjects' pharmacies. Receives: Behavioral: Social Media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
A medication possession ratio was calculated based on fill date information from the subjects' pharmacies
Measured: 6 months
Secondary outcomes (6)
Stress utilizing the Perceived Severity of Stress Questionnaire
Stress was measured by the Perceived Severity of Stress Questionnaire (PSQ)
Measured: 14 weeks
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
Measured: 14 weeks
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
Measured: 14 weeks
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")
Measured: 14 weeks
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.
Measured: 14 weeks
Empowerment
Empowerment was assessed using a validated quantitative Likert scale tool that measured 1) "empowering processes" (Appendix A), and 2) "empowering outcomes"
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start1 May 2014
- Primary completion31 Jan 2015
- Study completion31 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic LupusStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Miracle Network, Lupus Foundation of America
- Responsible party
- Principal investigator, Lisabeth Scalzi, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218033
- Sponsor's protocol ID
- 038689EP
- Status last verified
- Jul 2017
- First submitted
- 5 Jul 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scalzi LV, Hollenbeak CS, Mascuilli E, Olsen N. Improvement of medication adherence in adolescents and young adults with SLE using web-based education with and without a social media intervention, a pilot study. Pediatr Rheumatol Online J. 2018 Mar 14;16(1):18. doi: 10.1186/s12969-018-0232-2.
PubMed 29540181
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Medication Adherence in Adolescents With SLE Using Web-based Education With and Without a Social Media Intervention
- ClinicalTrials.gov ID
- NCT03218033
- Acronym / sponsor ID
- 038689EP
- Conditions
- Systemic Lupus
- Keywords
- systemic lupus, self-management, social media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Children's Miracle Network, Lupus Foundation of America
- Study start
- 1 May 2014 (actual)
- Primary completion
- 31 Jan 2015 (actual)
- Study completion
- 31 Jan 2015 (actual)
- First posted
- 14 Jul 2017 (actual)
- 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.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants visited the Facinglupustogether.com website and participated in consecutive weekly modules for 8 weeks. At the end of each module there were questions pertaining to the subject of each module. The control group answered the questions in provided journals and these were sent back to the investigator. All subjects completed surveys in REDCap prior to the study intervention and again 6 weeks after study completion to assess secondary outcome measures. Medication adherence was assessed by calculating a medication possession ratio by acquiring information on fill dates at the subjects' pharmacies. |
| Social Media (SM) | Active comparator | Behavioral: Social MediaThe intervention phase was 8 weeks in duration. Participants visited the Facinglupustogether.com website and participated in consecutive weekly modules. 8 The SM group answered the questions at the end of each module on a blogging site with other SM participants. SM participants were encouraged to provide feedback or questions about the material or personal questions that arose in response to each module. All subjects completed surveys in REDCap prior to the study intervention and again 6 weeks after study completion to assess secondary outcome measures. Medication adherence was assessed by calculating a medication possession ratio by acquiring information on fill dates at the subjects' pharmacies. |
Who may qualify
- Ages
- 13 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- age <13 or >23 years
- comorbid medical or psychiatric illness that would affect the outcome measures.
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 |
|---|---|---|
| Social Media | Behavioural | Social Media (SM) |
Primary outcome
Medication Adherence
Time frame: 6 months
A medication possession ratio was calculated based on fill date information from the subjects' pharmacies
6 secondary outcomes
Stress utilizing the Perceived Severity of Stress Questionnaire
Time frame: 14 weeks
Self-efficacy utilizing the Children's Arthritis Self-Efficacy scale
Time frame: 14 weeks
Quality of Life utilizing the Simple Measure of the Impact of Lupus Erythematosus in Youngsters (SMILEY) index
Time frame: 14 weeks
Sense of agency
Time frame: 14 weeks
Sense of community
Time frame: 14 weeks
Empowerment
Time frame: 14 weeks
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 14 Jul 2017.
- Derived from this study: PubMed 29540181Scalzi LV, Hollenbeak CS, Mascuilli E, Olsen N. Improvement of medication adherence in adolescents and young adults with SLE using web-based education with and without a social media intervention, a pilot study. Pediatr Rheumatol Online J. 2018 Mar 14;16(1):18. doi: 10.1186/s12969-018-0232-2.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Social Media in people with Systemic Lupus, run by Milton S. Hershey Medical Center.
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 3 inclusion and 2 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 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Medication Adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03218033, which also lists 1 linked publication.
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 14 Jul 2017.