Developing an Activity Pacing Framework: Feasibility and Acceptability

Chronic Pain Clinical Trial

Official title:

Developing an Activity Pacing Framework for the Management of Chronic Pain/Fatigue. Stage III: Feasibility and Acceptability Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03497585
• Other study ID #: IRAS:242203, V2.1, 27.04.18
• Status: Completed
• Start date: May 21, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2020
• Source: Pennine Acute Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Feasibility Study Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Chronic Low Back Pain
• Chronic Pain
• Fatigue
• Fatigue Syndrome, Chronic
• Fibromyalgia
• Low Back Pain

Intervention

Behavioral:
• Activity pacing framework
The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.

Locations

Country	Name	City	State
United Kingdom	The Pennine Acute Hospitals NHS Trust	Bury	Lancashire

Sponsors (3)

Lead Sponsor	Collaborator
Pennine Acute Hospitals NHS Trust	National Institute for Health Research, United Kingdom, University of Leeds

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Antcliff D, Campbell M, Woby S, Keeley P. Activity Pacing is Associated With Better and Worse Symptoms for Patients With Long-term Conditions. Clin J Pain. 2017 Mar;33(3):205-214. doi: 10.1097/AJP.0000000000000401. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Activity Pacing Questionnaire (APQ-28) From Baseline 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.	Change in activity pacing from baseline (pre-treatment: up to one week before the programme) to the end of the 6-week's programme
Secondary	Activity Pacing at Baseline: Activity Pacing Questionnaire (APQ-28)	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 measure activity pacing at baseline (pre-treatment: up to one week before the 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.	Baseline (pre-treatment: up to one week before the programme)
Secondary	Activity Pacing at the End of Treatment: Activity Pacing Questionnaire (APQ-28)	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 measure activity pacing at the end of the 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.	6-weeks (end of the programme)
Secondary	Activity Pacing at 3-months Follow up: Activity Pacing Questionnaire (APQ-28)	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 measure activity pacing at 3-months follow up after the end of the 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.	3-months follow-up (after the end of the 6-week's programme)
Secondary	Pain at Baseline: 11-point Numerical Rating Scale (NRS) of Pain	Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at baseline (pre-treatment: up to one week before the programme)	Baseline (pre-treatment: up to one week before the programme)
Secondary	Pain at the End of Treatment (6-weeks): 11-point Numerical Rating Scale (NRS) of Pain	Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at the end of the 6-week's programme.	6-weeks (end of the programme)
Secondary	Pain at 3-months Follow up: 11-point Numerical Rating Scale (NRS) of Pain	Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at 3-months follow up after the end of the 6-week's programme	3-months follow-up (after the end of the 6-week's programme)
Secondary	Depression at Baseline: Patient Health Questionnaire-9 (PHQ-9)	The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and =15=severe depression.	Baseline (pre-treatment: up to one week before the programme)
Secondary	Depression at the End of Treatment (6-weeks): Patient Health Questionnaire-9 (PHQ-9)	The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and =15=severe depression.	6-weeks (end of the programme)
Secondary	Depression at 3-months Follow-up: Patient Health Questionnaire-9	The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and =15=severe depression.	3-months follow-up (after the end of the 6-week's programme)
Secondary	Anxiety at Baseline: Generalised Anxiety Disorder Assessment (GAD-7)	The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and =15=severe anxiety.	Baseline (pre-treatment: up to one week before the programme)
Secondary	Anxiety at the End of Treatment (6-weeks): Generalised Anxiety Disorder Assessment (GAD-7)	The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and =15=severe anxiety.	6-weeks (end of the programme)
Secondary	Anxiety at 3-months Follow up: Generalised Anxiety Disorder Assessment (GAD-7)	The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and =15=severe anxiety.	3-months follow-up (after the end of the 6-week's programme)
Secondary	Self-efficacy at Baseline: Pain Self Efficacy Questionnaire (PSEQ)	The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at baseline (pre-treatment: up to one week before the programme). The range of total scores is 0-60 where PSEQ=40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ=16 are considered low.	Baseline (pre-treatment: up to one week before the programme)
Secondary	Self-efficacy at the End of Treatment: Pain Self Efficacy Questionnaire (PSEQ)	The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ=40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ=16 are considered low.	6-weeks (end of the programme)
Secondary	Self-efficacy at 3-months Follow up: Pain Self Efficacy Questionnaire (PSEQ)	The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at 3-months follow up after the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ=40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ=16 are considered low.	3-months follow-up (after the end of the 6-week's programme)
Secondary	Fatigue at Baseline: Chalder Fatigue Questionnaire (CFQ)	The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.	Baseline (pre-treatment: up to one week before the programme)
Secondary	Fatigue at the End of Treatment: Chalder Fatigue Questionnaire (CFQ)	The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.	6-weeks (end of the programme)
Secondary	Fatigue at 3-months Follow up: Chalder Fatigue Questionnaire (CFQ)	The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.	3-months follow-up (after the end of the 6-week's programme)
Secondary	Pain-related Anxiety, Fear and Avoidance at Baseline: Pain Anxiety Symptoms Scale-short Version (PASS-20)	The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at baseline (pre-treatment: up to one week before the programme). Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.	Baseline (pre-treatment: up to one week before the programme)
Secondary	Pain-related Anxiety, Fear and Avoidance at the End of Treatment: Pain Anxiety Symptoms Scale-short Version (PASS-20)	The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.	6-weeks (end of the programme)
Secondary	Pain-related Anxiety, Fear and Avoidance at 3-months Follow up: Pain Anxiety Symptoms Scale-short Version (PASS-20)	The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at 3-months follow up after the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.	3-months follow-up (after the end of the 6-week's programme)
Secondary	Physical and Mental Function at Baseline: 12-Item Short-Form Health Survey (SF-12)	The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at baseline (pre-treatment: up to one week before the programme). The two subscale scores have a maximum score of 100, where higher scores indicated better function.	Baseline (pre-treatment: up to one week before the programme)
Secondary	Physical and Mental Function at the End of Treatment: 12-Item Short-Form Health Survey (SF-12)	The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function.	6-weeks (end of the programme)
Secondary	Physical and Mental Function at 3-months Follow up: 12-Item Short-Form Health Survey (SF-12)	The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at 3-months follow up after the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function.	3-months follow-up (after the end of the 6-week's programme)
Secondary	General Health Status and Quality of Life at Baseline: EuroQol (EQ-5D-5L)	The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at baseline (pre-treatment: up to one week before the programme). The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.	Baseline (pre-treatment: up to one week before the programme)
Secondary	General Health Status and Quality of Life at the End of Treatment: EuroQol (EQ-5D-5L)	The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.	6-weeks (end of the programme)
Secondary	General Health Status and Quality of Life at 3-months Follow up: EuroQol (EQ-5D-5L)	The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at 3-months follow up after the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.	3-months follow-up (after the end of the 6-week's programme)