Journal of Rehabilitation Medicine 51-8 | Page 24

560 E. Gabrielsen Hjelle et al. personnel were instructed to offer to interrupt the interview or intervention and consider contacting their general practitioner, a family member or home-care services. RESULTS A total of 670 stroke patients were assessed for eligi- bility, of whom, 353 consented to participate. A final total of 322 participants were randomly assigned to the intervention (n = 166) or control (n = 156) group. The REC only gave permission to register information on the sex and age of the participants who declined to participate. Unfortunately, not all recruiting cen- tres provided complete data; however, in the largest recruiting centre the mean age of those who consented were 64.1 years compared with 64.4 years in the group who did not consent (p = 0.893). The proportion of men and women who consented, 60.8% and 39.2%, respectively, compared with 58.2% and 41.8% who did not consent (p = 0.679) shows no sex dispropor- tion in the groups.Thirty-one participants declined after initially giving consent, reasons are listed in the flow diagram (Fig. 1). Twenty-three participants (7.1%) in the intervention group and 14 (4.4%) in the control group were lost to follow-up at 6 months. Consequently, 285 participants (88.5%) completed the follow-up assessments at 6 months. Fig. 1 shows the participant flow diagram. Baseline characteristics were generally well balan- ced between the groups (Table I). A numerical diffe- rence was noted for depression (Yale), on which 17.5% of participants in the intervention group and 27.6% of those in the control group reported depression at T1. The participants’ mean age was 8 years younger than that of the average stroke patients admitted to hospitals in Norway; 5% more were men, and more patients scored ≤5 on the NIHSS upon hospital admission (70% vs 65%) (2). Analysis of the implementation fidelity showed that the intervention’s core components were delive- red according to protocol, although the intervention trajectories were individualized (32). Based on a composite score of the adherence measures (number of sessions, timeliness of starting, and duration of intervention), 80% of the intervention programmes were implemented with high fidelity. This means that Table I. Sample characteristics of the stroke study sample (n  = 322) at baseline Variable Demographics and psychosocial factors Age, years, mean (SD) Female sex, n (%) Living with someone, n (%) Education ≥ college/university degree (n  = 165; 155), n (%) Working prior to stroke (n  = 165; 156), n (%) Receiving rehabilitation services, n (%) No caring responsibility, n (%) Having social support, n (%) Clinical characteristics Stroke aetiology (n  = 147; 144), n (%) Ischaemic infarction Haemorrhage Stroke symptom localization (n  = 164; 151), n (%) Right Left Bilateral NIHSS, (n  = 126; 114), median (IQR) 0–5 6–10 11+ No comorbidity, n (%) UAS, (n  = 163; 156), median (IQR) MMSE, (n  = 63; 65), median (IQR) Outcome measurements Normal mood (GHQ-28<5) (n  = 160; 151), n (%) Stroke and Aphasia Quality of Life Scale (SAQOL-39g) (n  = 154; 143) (Scale: 1–5), median (IQR) Physical domain Communication domain Psychosocial domain Feeling sad or depressed (Yale), n (%) Sense of coherence (SOC-13) (Scale: 13–65), (n  = 165; 156), mean (SD) Feeling fatigued (FQ-1), (n  = 165; 156), mean (SD) Lee’s fatigue scale (Lee 5): (Scale: 1–10), (n  = 164; 156), mean (SD) Intervention group ( n  =  166) Control group ( n  =  156) 66 (12.1) 67 (40.4) 117 (70.5) 51 (30.8) 64 (38.6) 114 (68.7) 129 (77.7) 154 (98.8) 65 (13.3) 65 (41.7) 101 (63.7) 52 (33.3) 57 (36.5) 99 (63.5) 120 (76.9) 152 (97.4) 128 (87.1) 19 (12.9) 136 (94.4) 8 (5.6) 65 (45.8) 70 (49.3) 7 (4.9) 4.0 (1.0–7.0) 85 (67.5) 28 (22.2) 13 (10.3) 31 (18.7) 52 (50–52) 27 (25–29) 56 (41.2) 74 (54.4) 6 (4.4) 2.5 (1.0–6.0) 85 (74.6) 17 (14.9) 12 (10.5) 32 (20.5) 52 (50–52) 28 (26–30) 50 (30.0) 4.35 (3.7–4.5) 46 (29.0) 4.25 (3.7–4.6) 4.62 (4.0–4.9) 5.00 (4.8–5.0) 3.93 (3.3–4.5) 29 (17.5) 50.6 (5.4) 88 (53.3) 3.47 (1.8) 4.53 (3.9–4.8) 5.00 (4.8–5.0) 3.84 (3.2–4.3) 43 (27.6) 50.4 (5.8) 87 (55.8) 3.58 (1.9) SD: standard deviation; IQR: interquartile range; NIHSS: National Institutes of Health Stroke Scale; MMSE: Mini Mental Status Examination; UAS: Ullevaal Aphasia Screening. www.medicaljournals.se/jrm