NCT02717403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

April 7, 2016

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

7.2 years

First QC Date

March 18, 2016

Last Update Submit

June 14, 2023

Conditions

Keywords

Chronic Disease ManagementRheumatoid ArthritisFacebookSocial networkingInternetQuestionnairesSurveysPhone interview

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Control in Health Care Decisions assessed with the Control Preferences Scale (CPS-RA)

    6 months

Study Arms (3)

Facebook + Website Group

EXPERIMENTAL

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: QuestionnairesBehavioral: FacebookBehavioral: Educational Website

Educational Website Group

EXPERIMENTAL

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: QuestionnairesBehavioral: Educational Website

Pilot Testing Group

EXPERIMENTAL

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: FacebookBehavioral: Educational WebsiteBehavioral: Phone Interview

Interventions

QuestionnairesBEHAVIORAL

Participants complete a self response electronic questionnaire at baseline, and at three and six months.

Also known as: Surveys
Educational Website GroupFacebook + Website Group
FacebookBEHAVIORAL

Participant accesses Facebook page regarding rheumatoid arthritis.

Also known as: Social Media
Facebook + Website GroupPilot Testing Group

Participant accesses Educational Website on the internet about rheumatoid arthritis.

Educational Website GroupFacebook + Website GroupPilot Testing Group
Phone InterviewBEHAVIORAL

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

Pilot Testing Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older (usability test and RCT)
  • Staff of the Department of General Internal Medicine (usability test)
  • Diagnosis of rheumatoid arthritis by a rheumatologist (RCT)
  • Ongoing or prior treatment with traditional disease-modifying anti-rheumatic drugs or biologic agents (RCT)
  • 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)
  • Living in the community (not institutionalized, etc. ) (RCT)
  • Able to communicate in English (RCT)
  • Use internet on average at-least once a week (RCT);
  • Disease duration 10 years or less (RCT)
  • Familiarity with and participation in social media (e.g. Facebook) (usability test and RCT)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Surveys and QuestionnairesMedia Exposure

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthSociologySocial SciencesBehavioral SciencesBehavioral Disciplines and Activities

Study Officials

  • Angeles M. Lopez-Olivo, MD, PHD, MS

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2016

First Posted

March 23, 2016

Study Start

April 7, 2016

Primary Completion

June 7, 2023

Study Completion

June 7, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations