Clinical trial NCT02717403: Effects of Social Networking on Chronic Disease Management in Arthritis
Official title: Phase 2 & Phase 3, Effects of Social Networking on Chronic Disease Management in Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Disease Management
Rheumatoid Arthritis
Keywords: Chronic Disease Management
Rheumatoid Arthritis
Facebook
Social networking
Internet
Questionnaires
Surveys
Phone interview
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Rheumatology Research Foundation
First posted: 2016-03-23
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objectives:

The overall goal of this study is to use the principles of chronic disease management to develop and test an online social networking intervention using the FB platform in a randomized controlled trial. Our specific objectives are as follows:

Aim 1: To develop and establish an independent closed community in FB for patients with rheumatoid arthritis, providing an educational platform for disease self-management and the potential for engaging in social networking with peers (Phase 2).

Objective 1. To beta test the features and navigation buttons and panels in the newly developed website and FB group.

Objective 2. To evaluate the contents, ease of use and satisfaction with the newly developed website and FB group by patient advocates (consultants to the study) who participate as members of the Facebook community.

Aim 2: To evaluate the efficacy of the FB community intervention combined with an educational website to improve patients' self-management (including knowledge, which is the primary outcome), decision making and patient-reported outcomes compared with the educational website alone (Phase 3). We hypothesize that participation in an online closed community offering evidence-based information combined with peer interaction and support will improve patients' knowledge.

Detailed description: Pilot Testing Phase:

Five participants will be recruited to pilot test and give feedback on the control educational website and the FB community. Participants will have access to the educational website and FB, for a period of one week. The main purpose is to test ease of use and satisfaction with both platforms. After 1 week, research staff will call the participant to obtain feedback about the websites. The interview will last approximately 30 minutes and in the case the participant does not finish the interview, the investigators will conduct a follow-up phone interview.

Randomization Phase:

Participants will complete a self response electronic questionnaire at baseline. Participants then randomized into one of two arms: Intervention (FB + Website) and Control (Website alone). The participant will be shown how to access the website and the Facebook page on the internet about rheumatoid arthritis. Patients will be assessed at three and six months after baseline via email self response electronic questionnaires. This phase will recruit 220 participants.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older (usability test and RCT)
2. Staff of the Department of General Internal Medicine (usability test)
3. Diagnosis of rheumatoid arthritis by a rheumatologist (RCT)
4. Ongoing or prior treatment with traditional disease-modifying anti-rheumatic drugs or biologic agents (RCT)
5. Adequate cognitive status as determined by a research coordinator at recruitment. To assess the participant's capacity to take part in the interview, the interviewer will note and comment on the participant's spontaneous speech and capacity to write date at the time of consent. Participants should be oriented to person, place, date, time, and events (RCT)
6. Living in the community (not institutionalized, etc. ) (RCT)
7. Able to communicate in English (RCT)
8. Use internet on average at-least once a week (RCT);
9. Disease duration 10 years or less (RCT)
10. Familiarity with and participation in social media (e.g. Facebook) (usability test and RCT)

Exclusion Criteria:

1. Participants not willing to complete interviews or survey instruments (usability test and RCT)
2. Hospitalized (RCT)
3. Patients who do not verbally, written, or electronically consent to participate (usability test and RCT)

Primary outcomes:
measure: Participant Knowledge of Rheumatoid Arthritis assessed with the Patient Knowledge Questionnaire (PKQ-RA)
timeFrame: 6 months
Secondary outcomes:
measure: Control in Health Care Decisions assessed with the Control Preferences Scale (CPS-RA)
timeFrame: 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Angeles M. Lopez-Olivo, MD, PHD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lopez-Olivo MA, Foreman JT, Leung C, Lin HY, Westrich-Robertson T, Hofstetter C, des Bordes JKA, Lyddiatt A, Leong A, Willcockson IU, Peterson SK, Suarez-Almazor ME. A randomized controlled trial evaluating the effects of social networking on chronic disease management in rheumatoid arthritis. Semin Arthritis Rheum. 2022 Oct;56:152072. doi: 10.1016/j.semarthrit.2022.152072. Epub 2022 Jul 16.