NCT00646217.
| Methods | A randomised, treatment/comparison, repeated‐measures experimental design (July 2005‐February 2010) | |
| Participants | Spouse/partner caregivers of stroke survivors, Kansas, USA. Caregivers were included if they were aged 55 years or older, married or married equivalent, living with and caring for a spouse or/partner surviving a first‐ever stroke occurring 6‐36 months before enrolment, could participate by telephone and spoke English. | |
| Interventions | Intervention: Self‐Care TALK (detail on number not available) Mode of delivery: Telephone Aim: To test the effectiveness of a self‐care intervention for older, spouse caregivers of persons with stroke in reducing caregiving strain, promoting caregiver health and well‐being, self‐efficacy related to health, and in reducing depressive symptoms Comparison: No intervention (detail on numbers not available) |
|
| Outcomes | 1. Burden: M‐CSI: modified (caregiver strain) 2. Psychological health (depression): CED‐D (depression) 3. Health status and well‐being (physical health): SF‐36 v2, PCS (perceived physical health) 4. Health status and well‐being (self‐efficacy): SRAHP (self‐efficacy for health) No detail available on the scoring system for any of the outcomes Data collection time points: 2 and 6 months post‐enrolment |
|
| Notes | The principal investigator Cynthia Teel, University of Kansas School of Nursing, confirmed via email on 27 August 2017 that the trial registration was the only publication for this trial. Study data requested; author replied that no study data were available for inclusion in this review. Funding sources: none stated |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No detail available |
| Allocation concealment (selection bias) | Unclear risk | No detail available |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unable to blind due to nature of the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No detail available |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No detail available |
| Selective reporting (reporting bias) | Unclear risk | No detail available |
| Other bias | Unclear risk | No detail available |