Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Developing an Activity Pacing Framework: Feasibility and Acceptability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03497585
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : August 30, 2019
Sponsor:
Collaborators:
University of Leeds
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Deborah Antcliff, Pennine Acute Hospitals NHS Trust

Brief 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.

Condition or disease Intervention/treatment
Chronic Pain Fibromyalgia Chronic Fatigue Syndrome Chronic Low Back Pain Behavioral: Activity pacing framework

Detailed 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 HEE/NIHR ICA Clinical Lectureship.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developing an Activity Pacing Framework for the Management of Chronic Pain/Fatigue. Stage III: Feasibility and Acceptability Studies
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Activity Pacing Framework
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
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.




Primary Outcome Measures :
  1. Change in activity pacing questionnaire (APQ-28) from baseline to the end of the 6-week's programme [ Time Frame: 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).



Secondary Outcome Measures :
  1. Activity pacing at baseline: Activity pacing questionnaire (APQ-28) [ Time Frame: Baseline (pre-treatment: up to one week before the 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 measure activity pacing at baseline (pre-treatment: up to one week before the programme).


  2. Activity pacing at the end of treatment: Activity pacing questionnaire (APQ-28) [ Time Frame: 6-weeks (end of the 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 measure activity pacing at the end of the 6-week's programme.


  3. Activity pacing at 3-months follow up: Activity pacing questionnaire (APQ-28) [ Time Frame: 3-months follow-up (after 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 measure activity pacing at 3-months follow up after the end of the 6-week's programme.


  4. Pain at baseline: 11-point numerical rating scale (NRS) of pain [ Time Frame: Baseline (pre-treatment: up to one week before the programme) ]
    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)

  5. Pain at the end of treatment (6-weeks): 11-point numerical rating scale (NRS) of pain) [ Time Frame: 6-weeks (end of the programme) ]
    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. Pain at 3-months follow up: 11-point numerical rating scale (NRS) of pain [ Time Frame: 3-months follow-up (after the end of the 6-week's programme) ]
    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

  7. Depression at baseline: Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline (pre-treatment: up to one week before the programme) ]
    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)

  8. Depression at the end of treatment (6-weeks): Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 6-weeks (end of the programme) ]
    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.

  9. Depression at 3-months follow-up: Patient Health Questionnaire-9 [ Time Frame: 3-months follow-up (after the end of the 6-week's programme) ]
    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

  10. Anxiety at baseline: Generalised Anxiety Disorder Assessment (GAD-7) [ Time Frame: Baseline (pre-treatment: up to one week before the programme) ]
    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)

  11. Anxiety at the end of treatment (6-weeks): Generalised Anxiety Disorder Assessment (GAD-7) [ Time Frame: 6-weeks (end of the programme) ]
    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.

  12. Anxiety at 3-months follow up: Generalised Anxiety Disorder Assessment (GAD-7) [ Time Frame: 3-months follow-up (after the end of the 6-week's programme) ]
    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.

  13. Self-efficacy at baseline: Pain Self Efficacy Questionnaire (PSEQ) [ Time Frame: Baseline (pre-treatment: up to one week before the programme) ]
    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)

  14. Self-efficacy at the end of treatment: Pain Self Efficacy Questionnaire (PSEQ) [ Time Frame: 6-weeks (end of the programme) ]
    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.

  15. Self-efficacy at 3-months follow up: Pain Self Efficacy Questionnaire (PSEQ) [ Time Frame: 3-months follow-up (after the end of the 6-week's programme) ]
    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.

  16. Fatigue at baseline: Chalder Fatigue Questionnaire (CFQ) [ Time Frame: Baseline (pre-treatment: up to one week before the programme) ]
    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)

  17. Fatigue at the end of treatment: Chalder Fatigue Questionnaire (CFQ) [ Time Frame: 6-weeks (end of the programme) ]
    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.

  18. Fatigue at 3-months follow up: Chalder Fatigue Questionnaire (CFQ) [ Time Frame: 3-months follow-up (after the end of the 6-week's programme) ]
    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.

  19. Pain-related anxiety, fear and avoidance at baseline: Pain Anxiety Symptoms Scale-short version (PASS-20) [ Time Frame: Baseline (pre-treatment: up to one week before the programme) ]
    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)

  20. Pain-related anxiety, fear and avoidance at the end of treatment: Pain Anxiety Symptoms Scale-short version (PASS-20) [ Time Frame: 6-weeks (end of the programme) ]
    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.

  21. Pain-related anxiety, fear and avoidance at 3-months follow up: Pain Anxiety Symptoms Scale-short version (PASS-20) [ Time Frame: 3-months follow-up (after the end of the 6-week's programme) ]
    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.

  22. Physical and mental function at baseline: 12-Item Short-Form Health Survey (SF-12) [ Time Frame: Baseline (pre-treatment: up to one week before the programme) ]
    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)

  23. Physical and mental function at the end of treatment: 12-Item Short-Form Health Survey (SF-12) [ Time Frame: 6-weeks (end of the programme) ]
    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.

  24. Physical and mental function at 3-months follow up: 12-Item Short-Form Health Survey (SF-12) [ Time Frame: 3-months follow-up (after the end of the 6-week's programme) ]
    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.

  25. General health status and quality of life at baseline: EuroQol (EQ-5D-5L) [ Time Frame: Baseline (pre-treatment: up to one week before the programme) ]
    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)

  26. General health status and quality of life at the end of treatment: EuroQol (EQ-5D-5L) [ Time Frame: 6-weeks (end of the programme) ]
    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.

  27. General health status and quality of life at 3-months follow up: EuroQol (EQ-5D-5L) [ Time Frame: 3-months follow-up (after the end of the 6-week's programme) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population involves patients with conditions of chronic pain/fatigue, for example, chronic low back pain, chronic widespread pain, fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). The study population includes those patients who are referred to the physiotherapy departments of The Pennine Acute Hospitals NHS Trust and who attend a rehabilitation programme. The activity pacing framework will be used to structure and standardise the pacing component of the programme.
Criteria

Feasibility Study Inclusion Criteria:

  • Patients with an initial 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497585


Contacts
Layout table for location contacts
Contact: Deborah Antcliff, PhD, BSc 07769683646 Deborah.Antcliff@nhs.net

Locations
Layout table for location information
United Kingdom
The Pennine Acute Hospitals NHS Trust Recruiting
Bury, Lancashire, United Kingdom, BL9 7TD
Contact: Deborah Antcliff, PhD, BSc    07769683646    Deborah.Antcliff@nhs.net   
Sponsors and Collaborators
Pennine Acute Hospitals NHS Trust
University of Leeds
National Institute for Health Research, United Kingdom
Investigators
Layout table for investigator information
Principal Investigator: Deborah Antcliff, PhD, BSc Pennine Acute Hospitals NHS Trust
  Study Documents (Full-Text)

Documents provided by Deborah Antcliff, Pennine Acute Hospitals NHS Trust:
Informed Consent Form  [PDF] April 27, 2018


Publications of Results:
Layout table for additonal information
Responsible Party: Deborah Antcliff, Senior Physiotherapist/Researcher, Pennine Acute Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03497585     History of Changes
Other Study ID Numbers: IRAS:242203, V2.1, 27.04.18
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deborah Antcliff, Pennine Acute Hospitals NHS Trust:
Rehabilitation
Pain Management
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatigue Syndrome, Chronic
Fibromyalgia
Back Pain
Low Back Pain
Fatigue
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Virus Diseases
Encephalomyelitis
Central Nervous System Diseases