Psychosocial well-being after stroke
Assessed for eligibility (n=670)
Enrolment
Eligible (n=353)
Randomized (n=322)
Allocation
Allocated to intervention (n=166)
561
Excluded (n=317)
Reasons:
• Not meeting inclusion criteria (n=63)
• Declined to participate (n=211)
• Lost to competing studies (n=12)
• Other reasons (n=31)
Declined participation after initially giving
consent (n=31)
Reasons:
• Missed data collection deadline (n=8)
• Unavailable after discharge (n=5)
• Medical conditions (n=5)
• Death (n=4)
• Diagnosis change, not longer eligible (n=2)
• Overwhelmed (n=1)
• Too healthy to participate (n=1)
• Did not disclose reason (n=5)
Allocated to control (n=156)
Follow-Up
T2, 6 months
Lost to follow-up (n=14)
Reasons:
• Due to group allocation (n=2)
• Other medical condition (n=3)
• Unavailable after discharge (n=5)
• Did not disclose reason (n=3)
• Dead (n=1)
Lost to follow-up (n=23)
Reasons:
• Due to group allocation (n=5)
• Felt too healthy to participate (n=1)
• Other medical condition (n=8)
• Total burden of rehabilitation (n=2)
• Unavailable after discharge (n=4)
• Did not disclose reason (n=3)
Analysis
6 months
Intention to treat analysis (n=166)
Complete cases (n=143)
Intention to treat analysis (n=156)
Complete cases (n=142)
Fig. 1. Flow chart of the study.
the intervention trajectory was complete (≥6interven-
tion sessions); it began between 4 and 8 weeks (mean
49 days (n = 147)) after the stroke, and the frequency
and total duration were a maximum of 17 weeks from
session 1 to session 8.
Primary outcome
After dichotomizing the sum score, 99 of the 166
patients (59.6%) in the intervention group and 93 of
the 156 patients (59.6%) in the control group had nor-
mal mood (GHQ-28<5) at 6 months. Table II shows
that, compared with that at baseline, the proportion of
participants with normal mood increased in both the
intervention and control groups.
After controlling for the baseline characteristics and
recruitment centre, in the logistic regression model, no
benefit of the dialogue-based intervention was obser-
ved over usual care on mood at T2 (OR: 0.898: 95%
CI: 0.54–1.50, p = 0.680) .
By separately exploring the results for the interven-
tion and control groups, it was found that no baseline
characteristics demonstrated statistically significant
effects on mood at T2 in the intervention group. Two
baseline factors affected the odds of a normal mood
at T2 in the control group. Higher SOC (OR: 1.098,
95% CI: 1.01–1.19, p = 0.026) increased the odds of
normal mood, while comorbidities (OR: 0.282, 95%
CI: 0.09–0.83, p = 0.022) decreased the odds of normal
mood. This difference should be further explored when
the 12-month data are available.
J Rehabil Med 51, 2019