NCT07222696招募中不适用
Pilot Randomized Trial of Health Coaching for People With Rheumatoid Arthritis to Improve Mental Well-Being
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change from Baseline in Mean Scores in PHQ-8 at 6 months post intervention
研究概览
简要总结
The goal of this clinical trial is to learn if peer coaching works to reduce levels of anxiety and/or depression in adults diagnosed with Rheumatoid Arthritis (RA). The main questions it aims to answer are: Do people with RA who complete the intervention with a peer coach have lower levels of anxiety and/or depression at 6 months from baseline? Do people with RA who complete the intervention with a peer coach have lower levels of anxiety and/or depression at 6 months compared to those in the control arm?
Researchers will compare the peer coaching intervention to an active-control arm (where people without RA coach participants on general health and nutrition topics) to see if peer coaching works to reduce anxiety and/or depression.
Participants will meet with a coach every week for 9 weeks and complete several surveys before, during and after the intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Male or Female older than 18 years of age.
- •Have a diagnosis of Rheumatoid Arthritis by a rheumatologist and currently taking a Disease-Modifying Anti-rheumatic drug ( Conventional Disease-Modifying Anti-rheumatic drug and/or Biological Disease-Modifying Anti-rheumatic drug)
- •Have high levels of depression defined as PHQ-8 scores between 10 to 20, OR high levels of anxiety based on GAD-7 scores > 10
- •Speaks English or Spanish
- •Have access to the internet, a computer, and/or a smartphone
- •Resides or lives in any state of the US, including Puerto Rico
- •Willing to work with a peer coach or a coach
排除标准
- •Having a rheumatic disease other than RA (e.g., psoriatic arthritis, gout, lupus)
- •Nursing home resident
- •History of dementia or severe cognitive decline
- •Are currently bedbound
- •Severe depression defined as PHQ-8 scores of >20.
研究组 & 干预措施
Healthier
Experimental
Participants will have 9 telephone-delivered sessions, over a 9-12-week period, delivered by a peer coach (another person with RA). Data will be collected at baseline, midway through the intervention (after Session 4 of the intervention), 3 weeks after completion of the intervention, 6, 12, and 24 months after completion of the intervention using validated instruments.
干预措施: Peer Coach (Behavioral)
Healthy Horizons
Active Comparator
Participants from will have 9 telephone-delivered sessions over a 9-12-week period delivered by a coach (a person without RA but who has a different chronic condition like osteoarthritis or diabetes). Data will be collected at baseline, midway through the intervention (after Session 4 of the intervention), 3 weeks after completion of the intervention, 6, 12, and 24 months after completion of the intervention using validated instruments.
干预措施: Healthy Horizons (Behavioral)
结局指标
主要结局
Change from Baseline in Mean Scores in PHQ-8 at 6 months post intervention
时间窗: Baseline and 6 months after completing the intervention (35 weeks after baseline)
Patient Health Questionnaire-8 has a range 0-24, where a higher score means more distress. The questions ask about how often participants have been affected by certain events.
Difference in Mean Scores in PHQ-8 Between the Experimental Arm and the Active Control Arm at 6 Months Post Intervention
时间窗: Six months post intervention completion (Approximately 35 weeks after baseline)
Patient Health Questionnaire-8 has a range 0-24, where a higher score means more distress. The questions ask about how often participants have been affected by certain events. We will determine differences in mean scores in PHQ-8 between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms
Change from Baseline in Mean Scores in GAD-7 at 6 months post intervention
时间窗: Baseline and 6 months after completing the intervention (35 weeks after baseline)
General Anxiety Disorder-7 has a range 0-21, where a score of 0-4 means minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety and 15-21 severe anxiety. The questions ask about how often participants have been affected by certain events.
Difference in Mean Scores in GAD-7 Between the Experimental Arm and the Active Control Arm at 6 Months Post Intervention
时间窗: Six months post intervention completion (35 weeks after baseline)
General Anxiety Disorder-7 has a range 0-21, where a score of 0-4 means minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety and 15-21 severe anxiety. The questions ask about how often participants have been affected by certain events. We will determine differences in mean scores between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms,
次要结局
- Change from Baseline in Mean Scores in PROMIS Pain Interference Midway Through the Intervention(Baseline, Midway through the intervention (4 weeks after baseline))
- Change from Baseline in Mean Scores in PROMIS Pain Interference at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention (12 weeks after baseline))
- Change from Baseline in Mean Scores in PROMIS Pain Interference at 6 Months Post-Intervention Completion(Baseline, 6 months post intervention completion (35 weeks after baseline))
- Change from Baseline in Mean Scores in PROMIS Pain Interference at 12 Months Post-Intervention Completion(Baseline, 12 months post-intervention completion (61 weeks after baseline))
- Change from Baseline in Mean Scores in PROMIS Pain Interference at 24 Months Post-Intervention Completion(Baseline, 24 months post-intervention completion (113 weeks after baseline))
- Difference in Mean Scores in PROMIS Pain Interference Between the Experimental Arm and the Active Control Arm Midway Through the Intervention(Baseline, Midway through the intervention (4 weeks after baseline))
- Difference in Mean Scores in PROMIS Pain Interference Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention(12 weeks after baseline))
- Difference in Mean Scores in PROMIS Pain Interference Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion(Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline))
- Difference in Mean Scores in PROMIS Pain Interference Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline))
- Difference in Mean Scores in PROMIS Pain Interference Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline))
- Change from Baseline in Mean Scores in PROMIS Sleep Disturbance Midway Through the Intervention(Baseline, Midway through the intervention (4 weeks after baseline))
- Change from Baseline in Mean Scores in PROMIS Sleep Disturbance at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention (12 weeks after baseline))
- Change from Baseline in Mean Scores in PROMIS Sleep Disturbance at 6 Months Post-Intervention Completion(Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline))
- Change from Baseline in Mean Scores in PROMIS Sleep Disturbance at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline))
- Change from Baseline in Mean Scores in PROMIS Sleep Disturbance at 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline))
- Difference in Mean Scores in PROMIS Sleep Disturbance Between the Experimental Arm and the Active Control Arm Midway Through the Intervention(Baseline, Midway through the intervention (4 weeks after baseline))
- Difference in Mean Scores in PROMIS Sleep Disturbance Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention (12 weeks after baseline))
- Change from Baseline in Mean Scores in Short Form-12 at 6 Months Post-Intervention Completion(Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline))
- Difference in Mean Scores in PROMIS Sleep Disturbance Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion(Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline))
- Difference in Mean Scores in PROMIS Sleep Disturbance Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion(61 weeks after baseline))
- Difference in Mean Scores in PROMIS Sleep Disturbance Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline))
- Change from Baseline in Mean Scores in Short Form-12 Midway Through the Intervention(Baseline, Midway through the intervention (4 weeks after baseline))
- Change from Baseline in Mean Scores in Short Form-12 at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention(12 weeks after baseline))
- Change from Baseline in Mean Scores in PROMIS Physical Function Midway Through the Intervention(Baseline, Midway Through the Intervention (4 weeks after baseline))
- Change from Baseline in Mean Scores in Short Form-12 at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline))
- Change from Baseline in Mean Scores in Short Form-12 at 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline))
- Difference in Mean Scores in Short-Form 12 Between the Experimental Arm and the Active Control Arm Midway Through the Intervention(Baseline, Midway Through the intervention(4 weeks after baseline))
- Change from Baseline in Mean Scores in Lubben Social Isolation at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion( 61 weeks after baseline))
- Difference in Mean Scores in Short-Form 12 Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention(12 weeks after baseline))
- Difference in Mean Scores in Short-Form 12 Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion(Baseline, 6 Months Post-Intervention Completion(35 weeks after baseline))
- Difference in Mean Scores in Short-Form 12 Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion(61 weeks after baseline))
- Difference in Mean Scores in Short-Form 12 Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline))
- Change from Baseline in Mean Scores in PROMIS Physical Function at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention(12 weeks after baseline))
- Change from Baseline in Mean Scores in PROMIS Physical Function at 6 Months Post-Intervention Completion(Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline))
- Change from Baseline in Mean Scores in PROMIS Physical Function at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline))
- Change from Baseline in Mean Scores in PROMIS Physical Function at 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline))
- Difference in Mean Scores in PROMIS Physical Function Between the Experimental Arm and the Active Control Arm Midway Through the Intervention(Baseline, Midway through the intervention (4 weeks after baseline))
- Difference in Mean Scores in PROMIS Physical Function Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention(12 weeks after baseline))
- Difference in Mean Scores in PROMIS Physical Function Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion(Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline))
- Difference in Mean Scores in PROMIS Physical Function Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline))
- Difference in Mean Scores in PROMIS Physical Function Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completionn(Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline))
- Change from Baseline in Mean Scores in Lubben Social Isolation Midway Through the Intervention(Baseline, Midway through the intervention( 4 weeks after baseline))
- Change from Baseline in Mean Scores in Lubben Social Isolation at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention( 12 weeks after baseline))
- Change from Baseline in Mean Scores in Lubben Social Isolation at 6 Months Post-Intervention Completion(Baseline, 6 Months Post-Intervention Completion( 35 weeks after baseline))
- Change from Baseline in Mean Scores in Lubben Social Isolation at 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion( 113 weeks after baseline))
- Difference in Mean Scores in Lubben Social Isolation Between the Experimental Arm and the Active Control Arm Midway Through the Intervention(Baseline, Midway through the intervention(4 weeks after baseline))
- Difference in Mean Scores in Lubben Social Isolation Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention(12 weeks after baseline))
- Difference in Mean Scores in Lubben Social Isolation Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion(Baseline, 6 Months Post-Intervention Completion(35 weeks after baseline))
- Change from Baseline in Mean Scores in UCLA Loneliness Scale at 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline))
- Difference in Mean Scores in Lubben Social Isolation Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion(61 weeks after baseline))
- Difference in Mean Scores in Lubben Social Isolation Between the Experimental Arm and the Active Control Arm 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline))
- Change from Baseline in Mean Scores in Cohen Stress Scale Midway Through the Intervention(Baseline, Midway through the intervention(4 weeks after baseline))
- Change from Baseline in Mean Scores in Cohen Stress Scale at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention(12 weeks after baseline))
- Change from Baseline in Mean Scores in Cohen Stress Scale at 6 Months Post-Intervention Completion(Baseline, 6 Months Post-Intervention Completion(35 weeks after baseline))
- Change from Baseline in Mean Scores in Cohen Stress Scale at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion(61 weeks after baseline))
- Change from Baseline in Mean Scores in Cohen Stress Scale at 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline))
- Difference in Mean Scores in Cohen Stress Scale Between the Experimental Arm and the Active Control Arm Midway Through the Intervention(Baseline, Midway through the intervention (4 weeks after baseline))
- Difference in Mean Scores in Cohen Stress Scale Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention (12 weeks after baseline))
- Difference in Mean Scores in Cohen Stress Scale Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion(Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline))
- Difference in Mean Scores in Cohen Stress Scale Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline))
- Difference in Mean Scores in Cohen Stress Scale Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline))
- Change from Baseline in Mean Scores in UCLA Loneliness Scale Midway Through the Intervention(Baseline, Midway through the intervention (4 weeks after baseline))
- Change from Baseline in Mean Scores in UCLA Loneliness Scale at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention (12 weeks after baseline))
- Change from Baseline in Mean Scores in UCLA Loneliness Scale at 6 Months Post-Intervention Completion(Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline))
- Change from Baseline in Mean Scores in UCLA Loneliness Scale at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline))
- Difference in Mean Scores in UCLA Loneliness Scale Between the Experimental Arm and the Active Control Arm Midway Through the Intervention(Baseline, Midway through the intervention (4 weeks after baseline))
- Difference in Mean Scores in UCLA Loneliness Scale Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention (12 weeks after baseline))
- Difference in Mean Scores in UCLA Loneliness Scale Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion(Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline))
- Difference in Mean Scores in UCLA Loneliness Scale Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline))
- Difference in Mean Scores in UCLA Loneliness Scale Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline))
- Change from Baseline in Mean Scores in Pain Self-Efficacy Questionnaire Midway Through the Intervention(Baseline, Midway through the intervention (4 weeks after baseline))
- Change from Baseline in Mean Scores in Pain Self-Efficacy Questionnaire at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention (12 weeks after baseline))
- Change from Baseline in Mean Scores in Pain Self-Efficacy Questionnaire at 6 Months Post-Intervention Completion(Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline))
- Change from Baseline in Mean Scores in Pain Self-Efficacy Questionnaire at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline))
- Change from Baseline in Mean Scores in Pain Self-Efficacy Questionnaire at 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline))
- Difference in Mean Scores in Pain Self-Efficacy Questionnaire Between the Experimental Arm and the Active Control Arm Midway Through the Intervention(Baseline, Midway through the intervention (4 weeks after baseline))
- Difference in Mean Scores in Pain Self-Efficacy Questionnaire Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention (12 weeks after baseline))
- Difference in Mean Scores in Pain Self-Efficacy Questionnaire Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion(Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline))
- Difference in Mean Scores in Pain Self-Efficacy Questionnaire Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline))
- Difference in Mean Scores in Pain Self-Efficacy Questionnaire Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline))
- Change from Baseline in Mean Scores in PHQ-8 Midway Through the Intervention(Baseline, Midway through the intervention (4 weeks after baseline))
- Change from Baseline in Mean Scores in PHQ-8 at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention (12 weeks after baseline))
- Change from Baseline in Mean Scores in PHQ-8 at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline))
- Change from Baseline in Mean Scores in PHQ-8 at 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline))
- Difference in Mean Scores in PHQ-8 Between the Experimental Arm and the Active Control Arm Midway Through the Intervention(Baseline, Midway through the intervention (4 weeks after baseline))
- Difference in Mean Scores in PHQ-8 Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention (12 weeks after baseline))
- Difference in Mean Scores in PHQ-8 Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline))
- Difference in Mean Scores in PHQ-8 Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline))
- Change from Baseline in Mean Scores in GAD-7 Midway Through the Intervention(Baseline, Midway through the intervention (4 weeks after baseline))
- Change from Baseline in Mean Scores in GAD-7 at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention (12 weeks after baseline))
- Change from Baseline in Mean Scores in GAD-7 at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline))
- Change from Baseline in Mean Scores in GAD-7 at 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline))
- Difference in Mean Scores in GAD-7 Between the Experimental Arm and the Active Control Arm Midway Through the Intervention(Baseline, Midway through the intervention (4 weeks after baseline))
- Difference in Mean Scores in GAD-7 Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention(Baseline, 3 Weeks Post-Intervention (12 weeks after baseline))
- Difference in Mean Scores in GAD-7 Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion(Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline))
- Difference in Mean Scores in GAD-7 Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion(Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline))
研究者
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