Strength and Pain-Coping Through Resilience and Knowledge
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Pain Intensity as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)
研究概览
简要总结
Older adults who are 50 years of age and older with depressive symptoms, pain and difficulty with mobility will participate in the SPARK intervention study that includes 8 nurse visits in participants' homes to help participants with participants' pain and mood.
详细描述
SPARK (Strength and Pain-Coping through Resilience and Knowledge) is a home-based, nurse-delivered behavioral intervention designed to reduce pain interference and depressive symptoms among community-dwelling older adults with mobility limitations. Chronic pain and depression occurs together later in life and can impair daily function, independence, and overall well-being. Pain interference, how pain affects daily life, is a critical and actionable outcome that is closely linked to depressive symptoms. SPARK integrates evidence-informed strategies delivered through the Neighborhood Nursing model and brings the necessary care directly to the homes of the participants. The intervention comprises eight weekly individualized 1:1 nurse home visits that integrate goal-directed care planning, education on pain and mood self-management, and coordination with Neighborhood Nursing and Community Health workers to address barriers and leverage local resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The statistician will be responsible for randomization and the investigator and study team will not have knowledge if participants are assigned to intervention group or wait list control group.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-report pain >3 out of a 0 -10 scale that has lasted longer than 3 months and keeps subjects from doing at least one activity that subjects would like to do
- •Live in the community
- •Live in Central Maryland
- •Score a 5 or higher on the PHQ-9 (depression measure) at least two times during a two week period (screening call and then at first data collection visit)
- •Must be pre-frail (one or two criteria on frailty phenotype) or frail (three or more of the criteria on frailty phenotype)
- •One ADL or IADL limitation
排除标准
- •Hospitalized > 3 times in the last year
- •Participating in physical therapy
- •Have a terminal diagnosis (<1 year expected survival)
- •> moderate intellectual impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMSQ)
- •Unable to speak or understand English
研究组 & 干预措施
SPARK Intervention Arm
The intervention group will receive the intervention for 12 weeks. The wait list control group will have outcomes measured but will not receive the intervention at this time.
干预措施: SPARK (Behavioral)
Wait List Control Arm
Once the intervention group has completed the intervention the wait list control group will complete the intervention.
干预措施: SPARK (Behavioral)
结局指标
主要结局
Change in Pain Intensity as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)
时间窗: Baseline, 12 weeks and 24 weeks
The PROMIS Intensity is used to measure pain intensity on a scale of 0-10. Higher scores indicate more pain intensity.
Change in Pain Interference as assessed by the PROMIS Pain Interference
时间窗: Baseline, 12 weeks and 24 weeks
The Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference is a six item scale used to measure how much pain interferes with activities. The scores can range from 6-30. Higher scores indicate more pain interference with activities.
Change in Depressive Symptoms as assessed by the Patient Health Questionnaire 9 (PHQ-9)
时间窗: Baseline, 12 weeks and 24 weeks
The Patient Health Questionnaire 9 (PHQ-9) includes 9 questions related to the Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnostic criteria for major depression. The PHQ-9 scores range from 0-27. Higher scores indicate more depressive symptoms.
Change in Depressive Symptoms as assessed by the PROMIS 57
时间窗: Baseline, 12 weeks and 24 weeks
The Patient Reported Outcomes Measurement System (PROMIS)57 the Patient Reported Outcomes Measurement Information System (PROMIS) 57, which is includes an 8-item instrument that can be used to measure self-reported negative mood, view of self, and somatic symptoms. The score range for PROMIS 57 is 8-40. Higher scores indicate more depressive symptoms.
次要结局
- Change in Physical Function as assessed by the Katz Activities of daily living (ADL)(Baseline, 12 weeks and 24 weeks)
- Change in Physical Function as assessed by the Lawton's Instrumental Activities of Daily Living (IADL)(Baseline, 12 weeks and 24 weeks)