Informal caregiver training for people with chronic pain in musculoskeletal services (JOINT SUPPORT): protocol for a feasibility randomised controlled trial

被引:1
作者
Smith, Toby [1 ,2 ]
Khoury, Reema [2 ]
Ashford, Polly-Anna [2 ]
Hanson, Sarah [2 ]
Welsh, Allie [3 ]
Clark, Allan B. [2 ]
Dures, Emma [4 ,5 ]
Adams, Jo [2 ,6 ]
机构
[1] Univ Warwick, Warwick Med Sch, Coventry, England
[2] Univ East Anglia, Fac Med & Hlth Sci, Norwich, England
[3] Univ East Anglia, Sch Educ, Norwich, England
[4] Univ West England, Sch Hlth & Social Wellbeing, Bristol, England
[5] Bristol Royal Infirm & Gen Hosp, Acad Rheumatol, Bristol, England
[6] Univ Southampton, Sch Hlth Sci, Southampton, England
基金
美国国家卫生研究院;
关键词
PAIN MANAGEMENT; REHABILITATION MEDICINE; RHEUMATOLOGY; UNPAID CAREGIVERS; OLDER-ADULTS; SAMPLE-SIZE; FAMILY; INTERVIEW; DISEASE; BURDEN; PILOT;
D O I
10.1136/bmjopen-2022-070865
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Introduction Chronic musculoskeletal (bone, joint or muscle) pain is disabling. People with it frequently have difficulties in managing everyday activities. Individuals may rely on family members or friends to support them. These people are known as informal caregivers. No interventions have previously addressed the health needs of people with chronic musculoskeletal pain and their caregivers. In response, the JOINT SUPPORT programme was developed. In this study, we will assess the feasibility and acceptability of conducting a pragmatic, multicentre, randomised controlled trial (RCT) to test the clinical and cost-effectiveness of the JOINT SUPPORT programme to support these individuals. Methods and analysis This will be a mixed-methods feasibility RCT. We will recruit 80 patients with chronic musculoskeletal pain with their informal caregivers. Patients will be randomised to usual National Health Service (NHS) care OR usual NHS care plus a caregiver-patient dyad training programme (JOINT SUPPORT). This programme comprises of five, 1-hour, group-based sessions for patients and caregivers, delivered by trained physiotherapists or occupational therapists. It includes developing skills in: understanding pain, pacing, graded activity, fear avoidance and goal-setting, understanding benefits of physical activity and skills in medication management. This will be re-enforced with a workbook. After the group-based sessions, patients and caregivers will be supported through three telephone sessions with a therapist. Data collected at baseline and 3months will include: screening logs, intervention logs, fidelity checklists and clinical outcomes on quality of life, physical and emotional outcomes, adverse events and resource use. Qualitative research with 24 patient-caregiver dyads and 12 healthcare professionals will explore the acceptability of trial processes. Stop-go criteria will inform the progression to a full trial. Ethics and dissemination Ethical approval was obtained on 22 February 2022 (National Research Ethics Committee Number: 22/NW/0015). Results will be reported at conferences, peer-review publications and across social media channels.
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页数:13
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共 43 条
[1]   Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies [J].
Avery, Kerry N. L. ;
Williamson, Paula R. ;
Gamble, Carrol ;
Francischetto, Elaine O'Connell ;
Metcalfe, Chris ;
Davidson, Peter ;
Williams, Hywel ;
Blazeby, Jane M. .
BMJ OPEN, 2017, 7 (02)
[2]  
Bandura A., 1968, Social foundations of thought and action
[3]   Core outcome domains for clinical trials in non-specific low back pain [J].
Chiarotto, Alessandro u ;
Deyo, Richard A. ;
Terwee, Caroline B. ;
Boers, Maarten ;
Buchbinder, Rachelle ;
Corbin, Terry P. ;
Costa, Leonardo O. P. ;
Foster, Nadine E. ;
Grotle, Margreth ;
Koes, Bart W. ;
Kovacs, Francisco M. ;
Lin, Chung-Wei Christine ;
Maher, Chris G. ;
Pearson, Adam M. ;
Peul, Wilco C. ;
Schoene, Mark L. ;
Turk, Dennis C. ;
van Tulder, Maurits W. ;
Ostelo, Raymond W. .
EUROPEAN SPINE JOURNAL, 2015, 24 (06) :1127-1142
[4]   Developing and evaluating complex interventions: the new Medical Research Council guidance [J].
Craig, Peter ;
Dieppe, Paul ;
Macintyre, Sally ;
Michie, Susan ;
Nazareth, Irwin ;
Petticrew, Mark .
BMJ-BRITISH MEDICAL JOURNAL, 2008, 337 (7676) :979-983
[5]   Musculoskeletal Discomfort, Physical Demand, and Caregiving Activities in Informal Caregivers [J].
Darragh, Amy R. ;
Sommerich, Carolyn M. ;
Lavender, Steven A. ;
Tanner, Kelly J. ;
Vogel, Kasey ;
Campo, Marc .
JOURNAL OF APPLIED GERONTOLOGY, 2015, 34 (06) :734-760
[6]  
euroqol, EuroQol: EQ-5D
[7]   Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale [J].
Farrar, JT ;
Young, JP ;
LaMoreaux, L ;
Werth, JL ;
Poole, RM .
PAIN, 2001, 94 (02) :149-158
[8]   Assessing the relationship between chronic pain and cardiovascular disease: A systematic review and meta-analysis [J].
Fayaz, Alan ;
Ayis, Salma ;
Panesar, Sukhmeet S. ;
Langford, Richard M. ;
Donaldson, Liam J. .
SCANDINAVIAN JOURNAL OF PAIN, 2016, 13 :76-90
[9]   Chronic low-back pain in adult with diabetes: NHANES 2009-2010 [J].
Hassoon, Ahmed ;
Bydon, Mohamad ;
Kerezoudis, Panagiotis ;
Maloney, Patrick R. ;
Rinaldo, Lorenzo ;
Yeh, Hsin-Chieh .
JOURNAL OF DIABETES AND ITS COMPLICATIONS, 2017, 31 (01) :38-42
[10]   Reliability, validity and reference values of the Zarit Burden Interview for assessing informal caregivers of community-dwelling older persons with dementia [J].
Hébert, R ;
Bravo, G ;
Préville, M .
CANADIAN JOURNAL ON AGING-REVUE CANADIENNE DU VIEILLISSEMENT, 2000, 19 (04) :494-507