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Effects of Social Networking on Chronic Disease Management in Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717403
Recruitment Status : Active, not recruiting
First Posted : March 23, 2016
Last Update Posted : May 13, 2019
Sponsor:
Collaborator:
Rheumatology Research Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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
Chronic Disease Management Rheumatoid Arthritis 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.

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Study Type : Interventional  (Clinical Trial)
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 : April 7, 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


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 Name: Surveys

Behavioral: Facebook
Participant accesses Facebook page regarding rheumatoid arthritis.
Other Name: 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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. Participant Knowledge of Rheumatoid Arthritis assessed with the Patient Knowledge Questionnaire (PKQ-RA) [ Time Frame: 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) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717403


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Rheumatology Research Foundation
Investigators
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Principal Investigator: Angeles M. Lopez-Olivo, MD, PHD, MS M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02717403    
Other Study ID Numbers: 2015-0349
14038089 ( Other Grant/Funding Number: Rheumatology Research Foundation )
NCI-2016-00563 ( Registry Identifier: NCI CTRP )
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

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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:
Chronic Disease Management
Rheumatoid Arthritis
Facebook
Social networking
Internet
Questionnaires
Surveys
Phone interview
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Chronic Disease
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes
Pathologic Processes