Physical Therapist as Primary Assessor for Patients With Knee Pain in Primary Health Care. A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 主要终点
- Change From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-index
研究概览
简要总结
In order to manage the future increase in osteoarthritis consultation, patients with osteoarthritis could be assessed by a physical therapist first, so that other patients with more severe conditions could get faster access to a primary care physician. In Swedish primary care, physicians and physical therapists are primary assessors for patients with suspected knee osteoarthritis. However, it is unclear if there are any differences between these managements in improving health-related quality of life (HrQoL), pain, physical function and self-efficacy.
There are a limited amount of studies about the impact on HrQoL, pain intensity, self-efficacy and physical performance in patients with knee pain being assessed and evaluated by a physical therapist as a primary assessor.
The overall purpose of this study is to evaluate the effects on self-rated HrQoL, pain intensity, self-efficacy and physical performance with either a physical therapist or a physician as primary assessor for patients with knee pain within primary health care.
Problem statements
Which effect does a clinical pathway with a physical therapist as primary assessor for patients with knee pain...
- ... have on self-rated HrQoL compared with a physician as primary assessor?
- ... have on self-rated pain intensity compared with a physician as primary assessor?
- ... have on physical performance compared with a physician as primary assessor?
- ... have on self-efficacy compared with a physician as primary assessor?
It is expected that this study will show the effects of two different primary assessors for patients with knee pain consulting primary health care. The results could clarify which profession that is most appropriate to be the primary assessor for patients with knee pain in primary health care.
详细描述
Patient Recruitment Recruiters: Primary care centers.
Screening procedure: Nurses at the primary care centers will get information about the study and the screening protocol from the data collector and project leader. There will be contact persons at each recruiting unit that will be responsible for the protocols and to contact the data collector when a patient fulfills all the criteria for participation. The project leader will have regular contact with the contact persons at the recruiting units. All screening protocols will be sent to the data collector. All participants will get orally and written information about the study from the data collector, and patients will provide written informed consent.
Randomization: Using a computer-generated list of random numbers, participants will be randomly assigned to being assessed, diagnosed and treated either by a physiotherapist or a physician first. A project coordinator is included among the health care providers in the study, but will not be involved in the screening procedure nor the data collection. The project coordinator will manage the sequence generation, allocation concealment, enrolment and assignments of participants and keep the concealed randomization scheme and sequentially numbered, sealed envelopes in a locked cupboard (in the same building where the enrolment will be), only available for the project coordinator. The project coordinator reveals the allocation to the participant shortly after the baseline measurement and to the health care providers.
Participants and health care providers in both groups will be aware of the allocated group, whereas data collector, data analyst and statistician will be kept blinded of allocation until completion of all outcome assessments.
The blinded data collector and analyst (is a physical therapist) whom is not involved in assessing diagnosing and treating patients with knee osteoarthritis while the study is conducted.
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)
入排标准
- 年龄范围
- 38 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >38 years old
- •Knee pain most of the days the last month
- •Crepitus on active motion
- •Morning stiffness, duration less than 30 minutes
- •The patient has to understand the Swedish language to follow test instructions and to complete the self-administered questionnaires.
排除标准
- •Already been assessed/diagnosed by a healthcare provider for current knee pain.
- •knee pain due to a traumatic cause
- •other rheumatic or systemic diseases
- •severe somatic or mental disease
- •pregnancy.
结局指标
主要结局
Change From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-index
时间窗: 12 months
A Swedish version of Euroqol-5 dimensions-3 levels (EQ5D-3L) will be used to assess perceived self-rated health-related quality of life. The questionnaire contain five dimensions and results in an index ranging from -0,549 to 1 using the UK tariffs. An index of 1 indicate full health.
Change From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-VAS
时间窗: 12 months
A Swedish version of Euroqol-5 dimensions-3 levels (EQ5D-3L) will be used to assess perceived self-rated health-related quality of life. The EQ5D-VAS is a visual analogue scale ranging from 0 to 100, where 0 is worst imaginable health state and 100 is best imaginable health state.
次要结局
- Change From Pain Intensity at 12 Months(12 months)
- Change From Physical Function at 12 Months(12 months)
- Change From Self-efficacy at 12 Months(12 months)