Phase 2 & Phase 3, Effects of Social Networking on Chronic Disease Management in Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Participant Knowledge of Rheumatoid Arthritis assessed with the Patient Knowledge Questionnaire (PKQ-RA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
Participant Knowledge of Rheumatoid Arthritis assessed with the Patient Knowledge Questionnaire (PKQ-RA)
时间窗: 6 months
The Patient Knowledge Questionnaire (PKQ-RA) will measure this outcome.
次要结局
- Control in Health Care Decisions assessed with the Control Preferences Scale (CPS-RA)(6 months)