Developing an Activity Pacing Framework for the Management of Chronic Pain/Fatigue. Stage III: Feasibility and Acceptability Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme
研究概览
简要总结
This study explores whether it is feasible to use a newly developed activity pacing framework to standardise how activity pacing is instructed by healthcare professionals in rehabilitation programmes for patients with chronic pain/fatigue.
详细描述
Activity pacing is frequently advised in the management of chronic pain/fatigue, including chronic low back pain, chronic widespread pain/fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis. However, there is no agreed definition of 'activity pacing' and it is instructed in various ways. For some, pacing involves adapting/limiting activities (for example, breaking down tasks/having rests); while for others, pacing involves having consistent activities/gradually increasing activities. Furthermore, pacing has been associated with both improved symptoms (decreased fatigue/anxiety/depression) and worsened symptoms (increased pain/disability).
Due to the high prevalence and cost (personal and financial) of chronic pain/fatigue, it is imperative that coping strategies such as pacing are clearly defined and evidence-based. This study involves Stage III in the development of an activity pacing framework to standardise how pacing is instructed by healthcare professionals. Stage I: Online Survey of pacing involved 92 healthcare professionals (doctors/nurses/physiotherapists/occupational therapists/clinical psychologists). The survey findings, together with existing research were used to develop the pacing framework. The framework was further developed in Stage II: Nominal Group Technique (consensus meeting), involving four patients and six healthcare professionals.
Stage III will test the feasibility of implementing the pacing framework clinically, by using it to underpin existing rehabilitation programmes for chronic pain/fatigue. Patients will attend rehabilitation programmes at the study sites as per usual practice. Patients' participation in this study involves their completion of a booklet of questionnaires. The aim of this feasibility study is to explore whether the activity pacing framework is usable in the clinical setting, to explore recruitment/retention rates, together with changes in symptoms between the start and end of treatment, and at 3-months follow-up. Stage III will also explore the acceptability of the framework by undertaking interviews with the patients and healthcare professionals involved in the rehabilitation programmes. Stage III is expected to last 22 months.
Future study will test the framework in a clinical trial to assess the effects of pacing on patients' symptoms. The pacing framework has the potential to improve treatments by providing guidance on the components of pacing found to have benefits for patients.
This study is funded by a Health Education England/National Institute for Health Research (HEE/NIHR) Integrated Clinical Academic (ICA) Clinical Lectureship.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with an initial General Practitioner (GP)/hospital consultant referral to The Pennine Acute Hospitals NHS Trust with diagnoses of chronic low back pain, chronic widespread pain, fibromyalgia or CFS/ME, with a minimum symptom duration of 3 months.
- •Patients referred to a rehabilitation programme for chronic pain/fatigue
- •Patients aged ≥18 years
- •Patients able to read/write in English
排除标准
- •Patients with evidence of a serious underlying pathology, such as a current diagnosis of cancer
- •Patients with severe mental health/cognitive functioning issues
- •Acceptability Study (qualitative interviews) Inclusion Criteria:
- •Patients with an initial GP/hospital consultant referral to The Pennine Acute Hospitals National Health Service (NHS) Trust with diagnoses of chronic low back pain, chronic widespread pain, fibromyalgia or CFS/ME, with a minimum symptom duration of 3 months (as per the feasibility study).
- •Patients who attended a minimum of one session of the rehabilitation programme, who consented to the study and completed the first questionnaire booklet. Patients do not need to have completed the programme, since the interviews will include patients who both completed and did not complete the programme.
- •Qualified healthcare professionals delivering the rehabilitation programmes who received training in using the activity pacing framework: physiotherapists and psychological wellbeing practitioners employed by The Pennine Acute Hospitals NHS Trust and Pennine Care NHS Foundation Trust.
结局指标
主要结局
Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme
时间窗: Change in activity pacing from baseline (pre-treatment: up to one week before the programme) to the end of the 6-week's programme
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to assess the changes in activity pacing from baseline (pre-treatment: up to one week before the programme) to end of the programme (6-week's programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
次要结局
- Pain at Baseline: 11-point Numerical Rating Scale (NRS) of Pain(Baseline (pre-treatment: up to one week before the programme))
- Pain at the End of Treatment (6-weeks): 11-point Numerical Rating Scale (NRS) of Pain(6-weeks (end of the programme))
- Activity Pacing at Baseline: Activity Pacing Questionnaire (APQ-28)(Baseline (pre-treatment: up to one week before the programme))
- Activity Pacing at the End of Treatment: Activity Pacing Questionnaire (APQ-28)(6-weeks (end of the programme))
- Activity Pacing at 3-months Follow up: Activity Pacing Questionnaire (APQ-28)(3-months follow-up (after the end of the 6-week's programme))
- Pain at 3-months Follow up: 11-point Numerical Rating Scale (NRS) of Pain(3-months follow-up (after the end of the 6-week's programme))
- Depression at Baseline: Patient Health Questionnaire-9 (PHQ-9)(Baseline (pre-treatment: up to one week before the programme))
- Depression at the End of Treatment (6-weeks): Patient Health Questionnaire-9 (PHQ-9)(6-weeks (end of the programme))
- Depression at 3-months Follow-up: Patient Health Questionnaire-9(3-months follow-up (after the end of the 6-week's programme))
- Anxiety at Baseline: Generalised Anxiety Disorder Assessment (GAD-7)(Baseline (pre-treatment: up to one week before the programme))
- Anxiety at the End of Treatment (6-weeks): Generalised Anxiety Disorder Assessment (GAD-7)(6-weeks (end of the programme))
- Anxiety at 3-months Follow up: Generalised Anxiety Disorder Assessment (GAD-7)(3-months follow-up (after the end of the 6-week's programme))
- Self-efficacy at Baseline: Pain Self Efficacy Questionnaire (PSEQ)(Baseline (pre-treatment: up to one week before the programme))
- Self-efficacy at the End of Treatment: Pain Self Efficacy Questionnaire (PSEQ)(6-weeks (end of the programme))
- Self-efficacy at 3-months Follow up: Pain Self Efficacy Questionnaire (PSEQ)(3-months follow-up (after the end of the 6-week's programme))
- Fatigue at Baseline: Chalder Fatigue Questionnaire (CFQ)(Baseline (pre-treatment: up to one week before the programme))
- Fatigue at the End of Treatment: Chalder Fatigue Questionnaire (CFQ)(6-weeks (end of the programme))
- Fatigue at 3-months Follow up: Chalder Fatigue Questionnaire (CFQ)(3-months follow-up (after the end of the 6-week's programme))
- Pain-related Anxiety, Fear and Avoidance at Baseline: Pain Anxiety Symptoms Scale-short Version (PASS-20)(Baseline (pre-treatment: up to one week before the programme))
- Pain-related Anxiety, Fear and Avoidance at the End of Treatment: Pain Anxiety Symptoms Scale-short Version (PASS-20)(6-weeks (end of the programme))
- Pain-related Anxiety, Fear and Avoidance at 3-months Follow up: Pain Anxiety Symptoms Scale-short Version (PASS-20)(3-months follow-up (after the end of the 6-week's programme))
- Physical and Mental Function at Baseline: 12-Item Short-Form Health Survey (SF-12)(Baseline (pre-treatment: up to one week before the programme))
- Physical and Mental Function at the End of Treatment: 12-Item Short-Form Health Survey (SF-12)(6-weeks (end of the programme))
- Physical and Mental Function at 3-months Follow up: 12-Item Short-Form Health Survey (SF-12)(3-months follow-up (after the end of the 6-week's programme))
- General Health Status and Quality of Life at Baseline: EuroQol (EQ-5D-5L)(Baseline (pre-treatment: up to one week before the programme))
- General Health Status and Quality of Life at the End of Treatment: EuroQol (EQ-5D-5L)(6-weeks (end of the programme))
- General Health Status and Quality of Life at 3-months Follow up: EuroQol (EQ-5D-5L)(3-months follow-up (after the end of the 6-week's programme))
研究者
Deborah Antcliff
Senior Physiotherapist/Researcher
Pennine Acute Hospitals NHS Trust