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Effects of Social Networking on Chronic Disease Management in Arthritis

Primary Purpose

Chronic Disease Management, Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Questionnaires

Facebook

Educational Website

Phone Interview

About this trial

This is an interventional health services research trial for Chronic Disease Management focused on measuring Chronic Disease Management, Rheumatoid Arthritis, Facebook, Social networking, Internet, Questionnaires, Surveys, Phone interview

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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)

Sites / Locations

University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Facebook + Website Group

Educational Website Group

Pilot Testing Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Participant Knowledge of Rheumatoid Arthritis assessed with the Patient Knowledge Questionnaire (PKQ-RA)

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02717403

First Posted

March 18, 2016

Last Updated

June 14, 2023

Sponsor

M.D. Anderson Cancer Center

Collaborators

Rheumatology Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02717403

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

April 7, 2016 (Actual)

Primary Completion Date

June 7, 2023 (Actual)

Study Completion Date

June 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

Rheumatology Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Disease Management, Rheumatoid Arthritis

Keywords

Chronic Disease Management, Rheumatoid Arthritis, Facebook, Social networking, Internet, Questionnaires, Surveys, Phone interview

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

210 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Facebook + Website Group

Arm Type

Experimental

Arm Description

Arm Title

Educational Website Group

Arm Type

Experimental

Arm Description

Arm Title

Pilot Testing Group

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Questionnaires

Other Intervention Name(s)

Surveys

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Facebook

Other Intervention Name(s)

Social Media

Intervention Description

Participant accesses Facebook page regarding rheumatoid arthritis.

Intervention Type

Behavioral

Intervention Name(s)

Educational Website

Intervention Description

Participant accesses Educational Website on the internet about rheumatoid arthritis.

Intervention Type

Behavioral

Intervention Name(s)

Phone Interview

Intervention Description

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

Primary Outcome Measure Information:

Title

Participant Knowledge of Rheumatoid Arthritis assessed with the Patient Knowledge Questionnaire (PKQ-RA)

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35872394

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.

Results Reference

derived

Links:

URL

http://www.mdanderson.org

Description

University of Texas MD Anderson Cancer Center Website

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Effects of Social Networking on Chronic Disease Management in Arthritis

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