NCT03240913已完成不适用
A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty: Development and a Pilot Randomized Controlled Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Decision quality
研究概览
简要总结
The primary objectives of this study are to: 1) develop an educational tool known as the Patient Reported Outcome Measure informed Decision Aid (PROM-DA) that will describe the options for patients considering total knee arthroplasty (TKA) surgery, and help them imagine what to expect if they choose either option; 2) assess the extent that the PROM-DA improves patients decision quality; 3) determine the feasibility of a larger trial to test the PROM-DA in multiple sites and more patients.
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
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (age≥30) patients with knee osteoarthritis (OA)
- •Have an appointment with a surgeon for consultation about Total Knee Arthroplasty at the Edmonton Bone and Joint Centre
- •Understands, speaks and reads English; and
- •Able to provide informed consent.
排除标准
- •Individuals who have had prior total knee arthroplasty
- •Physician-diagnosed Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Fibromyalgia, or Gout.
研究组 & 干预措施
Treatment Group
Experimental
干预措施: Baseline and Follow-up Surveys (Behavioral)
Treatment Group
Experimental
干预措施: Patient Reported Outcome Measure informed Decision Aid (Other)
Non Treatment Group
Placebo Comparator
Conventional information
干预措施: Baseline and Follow-up Surveys (Behavioral)
Non Treatment Group
Placebo Comparator
Conventional information
干预措施: Pamphlet (Other)
结局指标
主要结局
Decision quality
时间窗: 40 to 52 weeks after baseline
Hip and Knee Decision Quality Instrument (HK-DQI)
次要结局
- Values(Baseline)
- Surgery(27 to 30 weeks after baseline)
- Decisional conflict(Baseline)
- Preference for involvement in decision making(Baseline)
- Treatment Preference(Baseline)
- Patient-reported shared decision-making(3 to 6 weeks after baseline)
- Depression(40 to 52 weeks after baseline)
- Decisional regret(40 to 52 weeks after baseline)
- Concordance(40 to 52 weeks after baseline)
- Quality of life (condition-specific)(40 to 52 weeks after baseline)
- Quality of life (generic)(40 to 52 weeks after baseline)
- Knowledge about total knee arthroplasty surgery(Baseline)
- Willingness to have surgery(Baseline)
- Expectations(40 to 52 weeks after baseline)
- Surgical consult(1 to 4 weeks after baseline)
- Satisfaction with knee replacement surgery(40 to 52 weeks after baseline)
研究者
研究点 (1)
Loading locations...
相似试验
终止
不适用
Educ'Avk: Recommendations for the Antivitamin K's GestionAVK TreatmentNCT00227097University Hospital, Grenoble300
已完成
不适用
Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced CancerAdvanced Lung CancerSmall Cell Lung Cancer Extensive StageStage IV Gastric CancerStage IV Hepatocellular CancerUnresectable Stage III Non-Small Cell Lung CancerStage IV Basal Cell CarcinomaStage IV Esophageal CancerStage IV Cutaneous Squamous Cell CarcinomaStage IV Renal Cell CarcinomaStage IV Head and Neck Squamous Cell CarcinomaStage IV Cervical CancerStage IV Endometrial CancerStage IV MesotheliomaImmune Checkpoint InhibitorsStage IV Non-Small Cell Lung CancerStage IV Merkel Cell CarcinomaStage IV Colorectal CancerImmunotherapyStage IV MelanomaUnresectable Non-Small Cell Lung CarcinomaStage IV Breast CancerStage IV Bladder CancerNCT04670445Massachusetts General Hospital199
已完成
不适用
Patient-centered Educational Material to Improve Colposcopy AdherenceCervical Cancer ScreeningNCT05762757Washington University School of Medicine25
招募中
不适用
Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint InhibitorsPsoriatic ArthritisAnkylosing SpondylitisCrohn DiseaseAutoimmune DiseaseEnteropathic SpondylitisReactive ArthritisInflammatory Bowel DiseaseEnteropathic ArthritisPsoriasisRheumatoid ArthritisMelanomaUlcerative ColitisSystemic Lupus ErythematosusNCT04751396M.D. Anderson Cancer Center125
已完成
不适用
Therapeutic Education Intervention in Breast Cancer: PEPs HormonotherapyBreast CancerNCT02300675Institut de Cancérologie de la Loire352