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. 2020 May 11;2020(5):CD003689. doi: 10.1002/14651858.CD003689.pub4

Goldberg 1997.

Study characteristics
Methods Study design: parallel design
Number arms: 2
Treatment arm: home‐based therapeutic intervention
Control arm: usual care
Participants Geographical location: USA
Setting: inpatient
Stroke criteria: unclear.
Method of stroke diagnosis: unclear.
Time since stroke: on average 2 weeks (treatment group) and 13 weeks (control group) prior to randomisation
Inclusion criteria: 1) home to return to and readily identified primary caregiver
Exclusion criteria: 1) severe pre‐morbid or co‐morbid conditions sufficient to impact significantly on their capacity to recover from the stroke; 2) residual cognitive or communicative impairment prevent participation in interviews
Total number randomised in this study: 55
Number randomised to treatment group: 27 (48% men, median age 72 years, range 65 to 84 years)
Number randomised to control group: 28 (55% men, median age 72 years, range 65 to 81 years)
Total number included in final analysis: 41
Number included in treatment group for final analysis: 21
Number included in control group for final analysis: 20
Interventions Treatment: weekly phone contact, monthly home visits; home‐based therapeutic team attend specifically to psychosocial stressors and prevent significant psychosocial problems from accelerating
Treatment duration: treatment continued for 1 year
Administered by: multidisciplinary team included a psychiatrist, psychologist, recreational therapist, research programme case manager, social worker
Supervision: case manager (social worker)
Intervention fidelity: not reported
Control: usual care, no visits
Follow‐up: last follow‐up at 1 year (end of treatment)
Outcomes Primary outcomes
  • Depression measured using the CES‐D


Secondary outcomes
  • Leaving the study early

  • Recurrent stroke

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "... subjects were randomized using a random number table to either the experimental group, which received the STAIR program, or to a control group, which did not." pp. 67
Allocation concealment (selection bias) Unclear risk Comments: method of allocation not reported
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "... since the subjects clearly could not be blinded to their own treatment." pp. 67
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "Blinding of the data collector was attempted, although this was difficult to consistently accomplish and maintain, since the subjects clearly could not be blinded to their own treatment."
Incomplete outcome data (attrition bias)
All outcomes High risk Comments: per protocol analysis reported only. 14/55 participants were not included in the analysis
Selective reporting (reporting bias) Unclear risk Comments: no trial protocol available to compare with the publication
Other bias Low risk Comments: there was no statistically significant difference between the treatment and control group in baseline demographic characteristics