Effects of Social Networking on Chronic Disease Management in Arthritis

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02717403
Collaborator
Rheumatology Research Foundation (Other)
210
1
3
83.8
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Questionnaires
  • Behavioral: Facebook
  • Behavioral: Educational Website
  • Behavioral: Phone Interview
Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Phase 2 & Phase 3, Effects of Social Networking on Chronic Disease Management in Arthritis
Actual Study Start Date :
Apr 7, 2016
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Facebook + Website Group

Participants complete a self response electronic questionnaire at baseline. Participant shown how to access the Educational Website and the Facebook page on the internet about rheumatoid arthritis. Patients assessed at three and six months after baseline via email self response electronic questionnaires.

Behavioral: Questionnaires
Participants complete a self response electronic questionnaire at baseline, and at three and six months.
Other Names:
  • Surveys
  • Behavioral: Facebook
    Participant accesses Facebook page regarding rheumatoid arthritis.
    Other Names:
  • Social Media
  • Behavioral: Educational Website
    Participant accesses Educational Website on the internet about rheumatoid arthritis.

    Experimental: Educational Website Group

    Participants complete a self response electronic questionnaire at baseline. Participant shown how to access the Educational Website on the internet about rheumatoid arthritis. Content includes the following: (i) a learning center; (ii) relevant links to other evidence-based web pages; (iii) news released by major rheumatology and dermatology organizations/societies; and (iv) chronic disease management strategies. Participants assessed at three and six months after baseline via email self response electronic questionnaires.

    Behavioral: Questionnaires
    Participants complete a self response electronic questionnaire at baseline, and at three and six months.
    Other Names:
  • Surveys
  • Behavioral: Educational Website
    Participant accesses Educational Website on the internet about rheumatoid arthritis.

    Experimental: Pilot Testing Group

    Participants access the Educational Website and Facebook page about rheumatoid arthritis for a period of one week. After 1 week, research staff calls participant to obtain feedback about the websites. The interview will last approximately 30 minutes.

    Behavioral: Facebook
    Participant accesses Facebook page regarding rheumatoid arthritis.
    Other Names:
  • Social Media
  • Behavioral: Educational Website
    Participant accesses Educational Website on the internet about rheumatoid arthritis.

    Behavioral: Phone Interview
    Research staff calls participant to obtain feedback about the websites. The interview will last approximately 30 minutes.

    Outcome Measures

    Primary Outcome Measures

    1. Participant Knowledge of Rheumatoid Arthritis assessed with the Patient Knowledge Questionnaire (PKQ-RA) [6 months]

      The Patient Knowledge Questionnaire (PKQ-RA) will measure this outcome.

    Secondary Outcome Measures

    1. Control in Health Care Decisions assessed with the Control Preferences Scale (CPS-RA) [6 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • Rheumatology Research Foundation

    Investigators

    • Principal Investigator: Angeles M. Lopez-Olivo, MD, PHD, MS, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02717403
    Other Study ID Numbers:
    • 2015-0349
    • 14038089
    • NCI-2016-00563
    First Posted:
    Mar 23, 2016
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by M.D. Anderson Cancer Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 30, 2022