Effects of Social Networking on Chronic Disease Management in Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Phase 2 & Phase 3, Effects of Social Networking on Chronic Disease Management in Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717403
• Other study ID #: 2015-0349
• Secondary ID: 14038089NCI-2016
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 7, 2016
• Est. completion date: June 7, 2023

Study information

• Verified date: June 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 7, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Chronic Disease
• Chronic Disease Management
• Rheumatoid Arthritis

Intervention

Behavioral:
• Questionnaires
Participants complete a self response electronic questionnaire at baseline, and at three and six months.
• Facebook
Participant accesses Facebook page regarding rheumatoid arthritis.
• Educational Website
Participant accesses Educational Website on the internet about rheumatoid arthritis.
• Phone Interview
Research staff calls participant to obtain feedback about the websites. The interview will last approximately 30 minutes.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Rheumatology Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Knowledge of Rheumatoid Arthritis assessed with the Patient Knowledge Questionnaire (PKQ-RA)	The Patient Knowledge Questionnaire (PKQ-RA) will measure this outcome.	6 months
Secondary	Control in Health Care Decisions assessed with the Control Preferences Scale (CPS-RA)	The Control Preferences Scale (CPS-RA) used to measure the degree of control an individual wants to assume while making decisions about their health care.	6 months

External Links

•   University of Texas MD Anderson Cancer Center Website