Effect of patient education on medication adherence of patients with rheumatoid arthritis: a randomized controlled trial

Figures & data

Figure 1 Patient flow chart.

Table 1 Baseline patient characteristics

Variables	Single intervention group (N=59)	Multi-component intervention group (N=60)
Female (%)	83.1	85
Age (years, mean ± SD)	57.20±12.24	55.82±11.25
Education attainment (n, %)
Under bachelor’s degree	69.5	75
Bachelor’s degree or above	30.5	25
Years of education (years, mean ± SD)	11.14±4.32	10.98±4.12
Employment status (n, %)
Employed	64.4	56.7
Unemployed	35.6	43.3
Income (10,000 baht/month, mean ± SD)	1.25±1.36	1.49±1.86
Marital status (n, %)
Single	15.3	10
Married	59.3	70
Divorce	11.9	5
Widow	13.6	15
Social health protection scheme (n, %)
CSMBS	49.2	56.7
Non-CSMBS	50.8	43.3
Underlying disease (n, %)
Diabetes mellitus	5.1	10
Hypertension	37.3	36.7
Dyslipidemia	32.2	31.7
Coronary artery disease	1.7	5
Chronic lung disease	1.7	3.3
Chronic kidney disease	0	1.7
Osteoporosis	27.1	18.3
History of alcohol use (n, %)	30.5	28.3
History of smoking (n, %)	15.3	10
Anxiety (n, %)	0	10
Depression (n, %)	1.7	6.7
Cognitive impairment (n, %)
TMSE	11.9	5
MoCA-T	62.7	53.3
B-IPQ domain (mean ± SD)
Consequences	4.03±2.64	3.72±2.74
Timeline	5.58±3.37	5.87±3.62
Personal control	5.76±2.85	6.65±2.90
Treatment control	8.25±2.20	8.60±2.25
Identity	3.97±2.48	4.08±2.66
Concern	4.00±3.17	4.03±3.32
Emotional responses	7.59±2.36	7.73±2.82
Illness comprehensibility	4.15±3.02	3.82±3.24

Abbreviations: B-IPQ, brief illness perception questionnaire; CSMBS, civil servants’ medical benefit scheme; HADS, hospital anxiety and depression scale; MoCA-T, Thai version of Montreal cognitive assessment; TMSE, Thai mental state examination.

Table 2 Baseline disease and treatment characteristics

Variables	Single intervention group (N=59)	Multi-component intervention group (N=60)
Disease duration (years, mean ± SD)	7.73±6.93	8.29±7.91
Duration of treatment (years, mean ± SD)	7.14±6.59	8.07±7.94
Extra-articular manifestation (%)	57.6	68.3
Sicca	33.9	46.7
Rheumatoid nodule	28.8	41.7
Interstitial lung disease	0.0	6.7
Cervical spine involvement	6.8	3.3
Autoantibodies
RF positive (N=116) (n, %)	71.2	70.0
ACPA positive (N=92) (n, %)	54.2	56.7
Number of medications (mean ± SD)	7.47±2.18	7.17±2.34
Type and dosage of DMARDs
MTX use (n, %)	76.3	81.7
MTX dosage (mg/week, mean ± SD)	12.17±3.94	12.14±4.33
SSZ use (n, %)	62.7	65.0
SSZ dosage (g/day, mean ± SD)	1.92±0.76	1.94±0.70
HCQ use (n, %)	27.1	28.3
HCQ dosage (mg/day, mean ± SD)	179.46±44.26	179.82±45.78
CQ use (n, %)	16.9	8.3
CQ dosage (mg/day, mean ± SD)	219.70±65.09	200.00±68.47
LEF use (n, %)	20.3	25.0
LEF dosage (mg/day, mean ± SD)	12.13±6.44	14.19±5.73
Prednisolone use (n, %)	32.2	40.0
Prednisolone dosage (mg/day, mean ± SD)	5.43±3.11	4.18±2.75
Biologics use (n, %)	1.7	1.7
History of adverse drug reaction (n, %)	20.3	33.3
DAS28 (mean ± SD)	3.24±1.19	3.20±0.90
EQ-5D (mean ± SD)	0.85±0.12	0.82±0.17
EQ-VAS (mean ± SD)	79.66±15.62	77.92±20.92
VAS pain (mean ± SD)	19.14±20.17	18.33±21.48
VAS PhGA mm, (mean ± SD)	14.66±17.29	13.90±17.03
Pill count adherence rate (%)	88.60±19.66	92.21±14.05
Good adherencea (n, %)	16.7	27.1
MTB-Thai 0–24, (mean ± SD)	21.61±2.67	21.68±1.91
Good adherenceb (n, %)	33.3	28.8

Notes:

a Good adherence defined as pill count adherence rate >80%.

b Good adherence defined as MTB-Thai ≥22.

Abbreviations: ACPA, anti-citrullinated protein antibody; CQ, chloroquine; EQ-5D, EuroQol 5 dimensions; EQ-VAS, EuroQol visual analog scale; DAS28, disease activity score 28; DMARDs, disease-modifying anti-rheumatic drugs; HCQ, hydroxychloroquine; LEF, leflunomide; MTB-Thai, Medication taking behavior questionnaire for Thai patient; MTX, methotrexate; RF, rheumatoid factor; SSZ, sulfasalazine; VAS pain, visual analog scale for pain; VAS PhGA, visual analog scale for physician global assessment.

Table 3 Disease parameters at baseline and 12 weeks of the single and multi-component intervention groups

Variables	Single intervention group (N=59)			Multi-component intervention group (N=60)
	At baseline	At 12 weeks	P-value	At baseline	At 12 weeks	P-value
Pill count adherence rate (%)	88.60±19.66	92.42±14.27	0.044	92.21±14.05	97.59±10.07	0.002
Good adherencea (n, %)	72.9	89.8	0.019	83.3	95	0.040
Adherence rate per each medication
MTX (%)	89.76±19.96	92.60±15.01	0.190	92.61±16.05	98.37±9.70	0.024
SSZ (%)	87.94±17.27	97.74±8.27	0.001	87.39±19.00	97.87±15.87	0.008
HCQ (%)	88.06±35.80	87.07±16.00	0.893	89.38±24.20	90.32±24.87	0.628
CQ (%)	95.32±11.80	96.19±13.50	0.788	105.18±4.40	103.94±7.53	0.585
LEF (%)	87.95±16.04	98.57±15.00	0.143	100.84±15.78	97.18±9.31	0.438
Prednisolone (%)	94.12±13.69	94.26±11.91	0.975	90.95±20.52	97.45±7.00	0.181
MTB score (mean ± SD)	21.61±2.67	22.05±1.91	0.251	21.68±1.91	22.80±1.34	<0.001
Good adherenceb (n, %)	71.2	71.2	1.000	66.7	85	0.020
DAS28 (mean ± SD)	3.24±1.19	3.17±1.23	0.563	3.20±0.90	3.01±1.05	0.160
EQ-5D (mean ± SD)	0.850±0.123	0.825±0.136	0.142	0.823±0.175	0.824±0.177	0.945
EQ-VAS (mean ± SD)	79.66±15.62	74.64±20.51	0.055	77.92±20.92	76.08±21.35	0.577
VAS pain (mean ± SD)	19.41±20.17	20.00±23.27	0.840	18.33±21.48	12.58±17.72	0.092
VAS PhGA (mean ± SD)	14.66±17.29	17.29±20.75	0.272	13.90±17.03	10.12±15.62	0.159
Anxietyc (n, %)	0	1.7	0.317	10	3.3	0.142
Depressionc (n, %)	1.7	3.4	0.560	6.7	3.3	0.724
B-IPQ domain (mean ± SD)
Consequences	4.03±2.64	3.47±2.57	0.160	3.73±2.77	3.54±2.98	0.594
Timeline	5.58±3.37	5.47±3.37	0.842	5.92±3.63.	6.32±3.47	0.423
Personal control	5.76±2.85	6.07±2.77	0.501	6.66±2.93	6.19±3.12	0.268
Treatment control	8.25±2.02	7.83±2.08	0.173	8.64±2.24	8.54±2.03	0.778
Identity	3.94±2.48	3.80±2.34	0.621	4.12±2.67	3.95±2.63	0.621
Concern	4.00±3.17	4.19±2.84	0.587	4.07±3.34	4.08±3.13	0.972
Emotional responses	7.59±2.36	7.78±1.90	0.551	7.75±3.84	7.95±2.47	0.670
Illness comprehensibility	4.15±3.02	4.44±3.05	0.520	3.81±3.27	3.49±2.94	0.329

Notes:

a Good adherence defined as pill count adherence rate >80%.

b Good adherence defined as MTB-Thai ≥22.

c Anxiety and depression defined as HADS score >10.

Abbreviations: B-IPQ, brief illness perception questionnaire; CQ, chloroquine; DAS28, disease activity score 28; EQ-5D, EuroQol 5 dimensions; EQ-VAS, EuroQol visual analog scale; HADS, hospital anxiety and depression scale; HCQ, hydroxychloroquine; LEF, leflunomide; MTB-Thai, medication taking behavior questionnaire for Thai patient; MTX, methotrexate; SSZ, sulfasalazine; VAS pain, visual analog scale for pain; VAS PhGA, visual analog scale for physician global assessment.

Table 4 Mean changes in disease parameters from baseline until the 12-week follow-up in both single and multi-component intervention groups

Variables	Single intervention group (N=59)	Multi-component intervention group (N=60)	P-value
	Mean difference	Mean difference
Pill count adherence rate (%)	3.81±14.23	5.38±12.90	0.531
Adherence rate per each medication
MTX (%)	2.83±13.45	5.76±16.78	0.379
SSZ (%)	9.80±16.64	10.48±23.05	0.887
HCQ (%)	−0.99±28.73	0.94±7.84	0.792
CQ (%)	0.87±9.88	−1.24±4.68	0.662
LEF (%)	10.62±18.20	−3.66±15.74	0.078
Prednisolone (%)	0.14±17.59	6.50±21.47	0.342
MTB score (mean ± SD)	0.44±2.92	1.12±2.22	0.157
DAS28 (mean ± SD)	−0.07±0.89	−0.20±1.06	0.476
EQ-5D (mean ± SD)	−0.025±0.131	0.002±0.173	0.341
EQ-VAS (mean ± SD)	−5.02±19.71	−1.83±25.31	0.446
VAS pain (mean ± SD)	0.59±22.52	−5.75±25.99	0.158
VAS PhGA (mean ± SD)	2.63±18.20	−3.78±20.56	0.074
B-IPQ domain (mean ± SD)
Consequences	−0.56±3.02	−0.19±2.67	0.479
Timeline	−0.10±3.90	0.41±3.87	0.478
Personal control	0.31±3.46	−0.47±3.26	0.210
Treatment control	−0.42±2.36	−0.10±2.76	0.479
Identity	−0.17±2.62	−0.17±2.62	1.000
Concern	019±2.62	0.02±3.68	0.774
Emotional responses	0.19±2.39	0.20±3.65	0.976
Illness comprehensibility	0.29±3.42	−0.32±2.52	0.272

Abbreviations: B-IPQ, brief illness perception questionnaire; CQ, chloroquine; DAS28, disease activity score 28; EQ-5D, EuroQol 5 dimensions; EQ-VAS, EuroQol visual analog scale; HCQ, hydroxychloroquine; LEF, leflunomide; MTB-Thai, medication taking behavior questionnaire for Thai patient; MTX, methotrexate; SSZ, sulfasalazine; VAS pain, visual analog scale for pain; VAS PhGA, visual analog scale for physician global assessment.