Development and Feasibility of a Mind-Body Intervention to Improve Physical Activity for Patients With Chronic Hip Pain: Open Pilot (HIPS Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Feasibility of recruitment
研究概览
简要总结
The goal of this study is to conduct a feasibility open pilot study (N=5) of HIPS with virtual exit interviews among adult patients with chronic hip joint-related pain (HRP). We will use this mixed methods information to assess the feasibility, credibility, and acceptability of the HIPS intervention and optimize the program and study methodology in preparation for a pilot feasibility randomized control trial (RCT).
Deliverables: [1] Adapt and refine open pilot protocol, patient recruitment, provider training, and other study materials. [2] Assess the feasibility, acceptability, and credibility of HIPS in preparation for a future feasibility RCT.
详细描述
Aim: Conduct a feasibility open pilot study (N=5) of HIPS with virtual exit interviews among adult patients with chronic HRP. The ultimate goal of this research is to assess the feasibility, credibility, and acceptability of the HIPS intervention and optimize the program and study methodology in preparation for a pilot feasibility randomized control trial (RCT).
HIPS Intervention: HIPS is a 6-session (one 30-minute session per week) mind-body intervention delivered virtually via live-video by a trained physical therapist (PT). In addition to participating in the HIPS intervention, all participants will attend their prescribed physical therapy with a physical therapist of their choosing. To minimize variability in physical rehabilitation, we will send the physical therapist the Clinical Practice Guidelines, which outline a standard-of-care rehabilitation protocol. Across the six 30-minute sessions, the HIPS intervention aims to teach relaxation and coping skills (e.g., SMART goal-setting, coping thoughts, deep breathing, and progressive muscle relaxation) and provides pain education. After each session, the participant is instructed to set and meet a physical activity SMART goal for the coming week. Within the program manual will be a log where the participant may track their completion of home practice. Each week, participants will receive a survey to formally report their daily home practice data over the last 7 days.
Following program completion, there will be a one-time 30-minute virtual exit interview to elicit subject perceptions of HIPS and any recommendations to improve intervention quality. This information will be used to further adapt and optimize HIPS prior to future efficacy testing.
Assessments: Baseline (0 weeks), post-test (6 weeks), and 6-month follow-up (30 weeks) survey assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Presenting with chronic (lasting ≥3 months) hip joint-related pain (HRP)
- •a. If ≥45yr, the physician will confirm no osteoarthritis via X-ray (Kellgren Lawrence [KL] grade 0-1)
- •Score ≥3 for current hip pain on the Pain Visual Analogue Scale (Pain VAS)
- •Exhibits poor psychosocial health by meeting ≥1 of the criteria listed below:
- •Score ≥ 20 on the Pain Catastrophizing Scale (PCS)
- •Score ≤ 40 on the Pain Self-Efficacy Questionnaire (PSEQ)
- •Score ≥ 17 on the Tampa Scale for Kinesiophobia (TSK-11)
- •Exhibits sedentariness by meeting ≥1 of the criteria listed below:
- •Physically active < 150mins/week according to the International Physical Activity Questionnaire (IPAQ)
- •Hip pain interferes with ability to be physically active
- •Dissatisfaction with current physical activity level
排除标准
- •Previous surgery on the symptomatic (painful) hip
- •Current pain referred from the lower back
研究组 & 干预措施
HIPS
A 6-session mind-body intervention that teaches patients with chronic hip joint-related pain (HRP) coping skills (e.g., SMART goal-setting, coping thoughts, deep breathing, and progressive muscle relaxation) and pain education.
干预措施: HIPS (Behavioral)
结局指标
主要结局
Feasibility of recruitment
时间窗: Baseline (0 Weeks)
The percent of eligible patients approached that agree to participate.
Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale
时间窗: Post-Test (6 Weeks)
Measured using the Client Satisfaction Scale which assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.
Therapist adherence
时间窗: Collected during intervention, an average of 6 weeks
Rate of interventionist's delivering the programs by following the established session topics and practices
Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire
时间窗: Baseline (0 Weeks)
Assessed using the Credibility and Expectancy Questionnaire which asks the participant to indicate how much they believe, right now, that the intervention they will receive will help manage their COP and related worry. Possible scores range from 3 to 27 for both the credibility and the expectancy subscales. Higher scores represent higher credibility and expectancy.
Feasibility of Assessments at Follow-Up
时间窗: Follow-Up (30 Weeks)
Rate of participant's completion of self-report measures, with no measures missing.
Rate at which program was accepted, measured by number of completed program sessions
时间窗: Post-Test (6 Weeks)
The proportion of participants who attend ≥4 of 6 sessions.
Feasibility of Assessments at Baseline
时间窗: Baseline (0 Weeks)
Rate of participant's completion of self-report measures, with no measures missing.
Feasibility of Assessments at Post-Test
时间窗: Post-Test (6 Weeks)
Rate of participant's completion of self-report measures, with no measures missing.
Adverse Events
时间窗: Collected during intervention, an average of 6 weeks
Any self-reported or observed negative events related to participation
Proportion of participants who report symptom improvements as measured by the Global Rating of Change Scale
时间窗: Post-Test (6 Weeks)
The proportion of participants who report overall improvement on the Global Rating of Change Scale. This measure includes a single question asking the patient to rate their change with respect to their hip condition over the last 6 weeks. Higher scores indicate better outcomes.
次要结局
- Pain Visual Analogue Scale (Pain-VAS)(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- International Hip Outcome Tool (iHOT-12)(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- PROMIS Pain Interference - Short Form 6b(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- Multidimensional Assessment of Interoceptive Awareness (MAIA)(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- International Physical Activity Questionnaire (IPAQ)(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- Pain Catastrophizing Scale (PCS)(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- Tampa Kinesiophobia Scale (TSK)(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- Pain Self-Efficacy Questionnaire (PSEQ)(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- Whole Person Health Index (WPHI)(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- Change in Step Count via the ActiGraph wGT3X-BTLE Accelerometer(Baseline (0 Weeks), Post-Test (6 Weeks))
研究者
Kate Jochimsen
Principal Investigator
Massachusetts General Hospital