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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.
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