Does Arthritis Self-management Help?

A Randomised Controlled Trial of an Arthritis Self-

Management Programme in Primary Care

The Trial

Grant Holders:

Marta Buszewicz, Greta Rait, Mark Griffin University College London

Andy Haines London School of Hygiene & Tropical Medicine Julie Barlow University of Coventry

Project Manager: Angela Atkinson UCL

Health Economists: Jeni Beecham, Anita Patel Centre for the Economics of Mental Health

Intervention provided by Arthritis CareRCT funded by the MRC

Contents of Presentation

Background to the DASH trial

Study design

Working with the voluntary sector

Results

Discussion points

Background Osteoarthritis is a common & chronic condition,

causing: Pain & functional disability Anxiety & depression Lowered quality of life

It is associated with high direct (medical) & indirect (social & community costs Estimated total cost of £ 5.5 billion in 1999-2000

Perception that ‘medical’ treatments do not address many problems patients have

Previous results from studies examining arthritis self- management programmes

in the USA & UK

Improvements in anxiety & depression, exercise taken, sense of control over arthritis & better communication with doctors (reduced pain in some studies)

Sustained use of self-management techniques

Decrease in visits to doctors (in some studies)

Results so far with volunteer patients only

Recent systematic reviews raise some queries about methodology and effect sizes

Arthritis Self-Management Programmes (ASMPs)

Developed in the USA – started pragmatically, but theoretical basis in Bandura’s self-efficacy theory

People with arthritis are a resource – have innate problem solving skills

Effective self-management techniques are taught by trained volunteers who have arthritis

Key component is building on small experiences of mastery with peers

“Challenging Arthritis” (ASMP delivered by Arthritis Care)

Six, weekly, structured group sessions

Education about condition & its management

Help individual to develop individual behavioural and cognitive strategies

Aim to improve communication with family & health professionals

Quality assured

‘Expert Patients’ Initiative

UK government initiative to address living with chronic diseases – first introduced in 2002 Expert Patients’ Programme

Generic self-management programmes Based on Lorig’s US self management programmes

Funded initially by the government via PCTs National roll-out before pilot evaluations complete No clear evidence of cost-effectiveness Recent RCT results very similar to ours for ASMP

Study Objectives

To assess whether, for primary care patients in UK, with GP diagnosis of osteoarthritis:

participation in ‘Challenging Arthritis’ groups improves quality of life (1o outcome)

participation affects pain, function, control over symptoms, anxiety or depression (2o outcomes)

the intervention is cost-effective

(also a qualitative arm led by team in Coventry)

Study Design Randomised controlled trial

• Intervention: Challenging Arthritis course + education booklet

• Comparison: Education booklet only

Sample size• 1000 patients aimed for from power calculation• Recruited from the MRC GP Research Framework & other

primary care research networks

Selection of practices• Availability of ‘Challenging Arthritis’ nationally

Inclusion & Exclusion Criteria

Age 50 years or above

GP diagnosis of osteo-arthritis of knees and / or hips

Problems for 1 year+

Significant pain & disability in past month

Too immobile to attend course

Knee / hip pain under investigation

Referral for OA surgery

Neurological signs

Inability to complete questionnaires

Outcomes to be Measured

Measured at baseline, 4 & 12 months

10 Quality of Life (SF 36) 20

Pain, Functional Disability (WOMAC)

Control over Symptoms (arthritis self-efficacy)

Anxiety and Depression (HADS)

Cost-effectiveness (CSRI)

Health Status (Euroquol)

Patient Identification & Recruitment

Nurse computer searches Read code diagnoses Repeat prescriptions for NSAIDs & analgesics

GP identification Patients seen in surgery over 4-6 week period

Letter sent to potential participants inviting for :Research nurse interview

Eligibility checked, consent & baseline questionnaires

Followed by contact with Project Manager Telephone randomisation and course information sent

Qualitative methodology

Sample of the intervention group interviewed

Baseline, 4 & 12 months Purposively sampled for age, gender, ASE score Initially 30 patients – complete interviews on 17

Aims: To examine patients’ perceptions and attitudes towards

the ‘Challenging Arthritis’ intervention To explore how they felt about being referred to an ASMP

via their general practice

Collaboration with the Voluntary Sector

DASH was the first MRC trial working with the voluntary sector

Arthritis Care is a national voluntary organisation supporting people with arthritis – activities include -

Support, education and campaigning Delivery of ‘Challenging Arthritis’ & other courses

Arthritis Care

Structure of organisation Initially centralised & hierarchical Paid management & unpaid volunteers Funding for Challenging Arthritis courses

Aim to be self-funding, including ‘central costs’Contracts traditionally set up with HAs and other

organisationsAim to add to evidence in support of CA courses

Analysis Plan

Participants analysed in randomisation group originally assigned to (ITT), with imputation of missing data

Primary comparison evaluated the long-term effects of the intervention @ 12 months

Analysis of co-variance (ANCOVA) accounting for baseline score with multiple imputation

• Further Analyses   ‘Per protocol imputation’ – accounting for compliance with

intervention (>= 4 sessions) Analysis of data on those with ‘complete’ data only

Results - recruitment

B aseline

4 m onths

12 m onths

N ot elig ib le(n = 166)

R efused(n = 1027)

N o response(n = 776)

N ot elig ible at in terv iew(n = 35)

R efused(n = 75)

R esponse ra te 72%(n = 294)

R esponse ra te 76%(n = 307)

R esponse ra te 95%(n = 386)

In te rvention(n = 406)

R esponse ra te 80%(n = 325)

R esponse ra te 84%(n = 340)

R esponse ra te 94%(n = 382)

C ontrol(n = 406)

R andom ised(n = 812)

Patients attending screening in terview(n = 922)

Patients aged > 50 approached w ith possib le O A of h ips/knees(n = 2891)

  Intervention n=406

Control n=406

Age (yrs) Mean (S.D.) 

68.4 (8.2) 68.7 (8.6)

Gender Female

 

255(62.8%)

255(62.8%)

Owner Occupier 323(82.6%)

302(78.6%)

Ethnicity White

 

388(99.5%)

382(99.2%)

Age left school < 16 years

249(63.8%)

259(67.6%)

Higher education 

107(27.6%)

102(26.7%)

Results – baseline characteristics

Results – Challenging Arthritis course attendance

219 people in the intervention group (56 %) attended >= 4 intervention sessions

29% did not attend any of the sessions

OUTCOMES Adjusted difference in means & (95% C.I.) at 4 months

Adjusted difference in means & (95% C.I.) at 12 months

SF 36 MENTAL HEALTH Intention to Treat (ITT)Per protocol analysis

  0.11 (-1.18,1.40) 0.82 (-0.94,2.57)

  1.35 (-0.03, 2.74) 1.56 (- 0.28, 3.39)

SF 36 PHYSICAL HEALTH Intention to Treat (ITT)Per protocol analysis

  0.22 (-1.5, 1.94) - 0.37 (-2.02,1.28)

 0.33 (- 1.31, 1.98)0.24 (- 1.63, 2.11)

WOMAC PAIN Intention to Treat (ITT)Per protocol analysis

  - 0.15 (- 0.57,0.28) - 0.30 (- 0.79,0.19)

 - 0.33 (- 0.78, 0.13)- 0.47 (- 1.05, 0.10)

WOMAC STIFFNESS Intention to Treat (ITT)Per protocol analysis

  - 0.05 (-0.28,0.17) - 0.12 (- 0.36,0.11)

 - 0.17 (- 0.43, 0.09)- 0.13 (- 0.40, 0.14)

WOMAC FUNCTIONIntention to Treat (ITT)Per protocol analysis

  - 1.22 (- 2.59, 0.16) - 0.80 (- 2.24, 0.63)

 - 1.17 (- 2.84, 0.50)- 0.95 (- 2.63, 0.74)

HADS ANXIETY Intention to Treat (ITT)Per protocol analysis

  - 0.36 (- 0.76,0.05) - 0.68 (- 1.15,- 0.20) *

 - 0.62 (-1.08,- 0.16) *- 0.72 (-1.24,- 0.21) *

HADS DEPRESSION Intention to Treat (ITT)Per protocol analysis

  - 0.40 (- 0.76,- 0.03) * - 0.57 (- 0.96,- 0.18) *

 - 0.41 (- 0.82, 0.01)- 0.33 (- 0.76, 0.10)

ASE - PAIN Intention to Treat (ITT)Per protocol analysis

  1.63 (0.83, 2.43) * 2.55 (1.56, 3.56) *

  0.98 (0.07, 1.89) * 1.43 (0.37, 2.48) *

ASE - OTHER Intention to Treat (ITT)Per protocol analysis

  1.83 (0.74, 2.92) * 2.81 (1.74, 3.87) *

  1.58 (0.25, 2.90) * 1.54 (0.48, 2.60) *

Outcome plots - positive difference in means favours

treatment :

Adjusted Difference in Means

Adjusted Difference in Means

95% CI 95% CI

4 mth intention to treat 0.81 [-0.84, 2.46] 12 mth intention to treat 2.15 [0.15, 4.15]

-4 -2 0 2 4 Favours control

Favours treatment

Adjusted Difference in Means

Adjusted Difference in Means

95% CI 95% CI

4 mth intention to treat 0.12 [-2.05, 2.28] 12 mth intention to treat 0.53 [-1.51, 2.58]

-4 -2 0 2 4 Favours control Favours treatment

SF 36 Mental Health

SF 36 Physical Health

Outcome plots continued

ASE Pain

ASE Other

Outcome plots - negative difference in means favours

treatmentHADS Anxiety

HADS Depression

Outcome plots continued

Adjusted difference in means

Adjusted difference in means

95% CI 95% CI

4 mth intention to treat -0.34 [-0.89, 0.20]

12 mth intention to treat -0.38 [-0.89, 0.13] -1 -0.5 0 0.5 1

Favours treatment Favours control

Adjusted Differencein Means

Adjusted Differencein Means

95% CI 95% CI

4 mth intention to treat -0.15 [-0.37, 0.08]

12 mth intention to treat -0.16 [-0.40, 0.09] -1 -0.5 0 0.5 1

Favours treatment Favours control

Adjusted Difference in Means

Adjusted Differencein Means

95% CI 95% CI

4 mth intention to treat -1.28 [-2.97, 0.40]

12 mth intention totreat

-0.88 [-2.91, 1.14] -4 -2 0 2 4

Favours treatment Favours control

WOMAC Pain

WOMAC Stiffness

WOMAC Physical Functioning

12 Month Results - Summary

Small non significant change in SF-36 mental health scale

Significant differences occurred in: Reduced anxiety Improved self efficacy – pain and ‘other’

No significant change in: Function, pain, stiffness, depression (after 4 months) GP/nurse attendance & costs of medication Number of ‘clinically’ anxious participants No significant differences in other health & social care costs

Economic Evaluation

No significant differences between groups at 12 months in: Costs to statutory services (health & social care) Costs to patient, family, friends Indirect costs – time off work (patient / carer) Total costs – including & excluding ASMP cost

Cost effectiveness Acceptability Curves (CEACs) Small advantages on SF-36 translated into low incremental cost-effectiveness ratios & high probabilitiesof cost effectiveness for societal costs, but not health /social care costs

Cost-effectiveness conclusions based on QALYs incremental cost / QALY exceed range suggested by NICE

Summary / Discussion (1)

Does arthritis self-management work? Statistically significant, but small changes in anxiety and

ASE at 12 months (and mental health SF 36 on straight imputation)

Trend in all outcomes favouring the intervention What do these mean (a) clinically (b) for patients

Qualitative work suggests

? patients recruited from primary care less severely unwell & several interviewed already self-manage

Summary / Discussion (2)

How does the intervention work? How might the intervention impact on anxiety and

self-efficacy in terms of a complex intervention Is it a mental health intervention? Are there a sub-group likely to do particularly well

Economic Evaluation Should this be supplied on the NHS as it stands ?

Policy What does this mean for the Expert Patient

Initiative advocating self-management courses for a range of chronic diseases and funded by PCTs?