Gustafson 2019.
| Study characteristics | ||
| Methods |
Design: Parallel randomised clinical trial. No. of participating centres: One. Wisconsin, USA. Study dates: Not reported. |
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| Participants |
Inclusion criteria: Primary caregivers for a patient with dementia, providing care in the patient's home, and able to read English. Exclusion criteria: No stated. No. of participants randomised to intervention: ‐ D‐CHESS (n=16). ‐ Control group (n=15). Baseline characteristics: ‐ Caregivers: 19 females and 12 males. ‐ Care recipients: Mean Clinical Dementia Rating score 1.55 (SD=0.93), range from 0.5 (very mild dementia) to 3.0 (severe dementia). |
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| Interventions |
Experimental: Dementia‐Comprehensive Health Enhancement Support System (D‐CHESS). Control: Emailed informative book without any further training. Length of intervention: 6 months. |
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| Outcomes |
Primary outcomes: ‐ Caregiver burden assessed with a 6‐item caregiver load scale. ‐ Family conflict assessed with a 12‐item adapted scale. ‐ Satisfaction with care decisions assessed with the 6‐item Satisfaction with Decision Scale. ‐ Social support assessed with the 14‐item MOS Social Support Survey. ‐ Anxiety assessed with the 7‐item Generalised Anxiety Disorder scale. ‐ Depression assessed with the 8‐item Patient Health Questionnaire. ‐ Loneliness assessed with the 20‐item UCLA Loneliness Scale. ‐ Coping competence assessed with an ad‐hoc 9‐item scale. Secondary outcomes: ‐ Not stated. Outcomes assessment: At 6 months. |
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| Notes |
Clinical trial registration code: Not reported. Funding: Internal funds; University of Wisconsin‐Madison. Conflicts of interest: Authors state nothing to disclose. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: The randomization procedure is not described. |
| Allocation concealment (selection bias) | Unclear risk | Comment: There is no information on allocation concealment. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: The D‐CHESS intervention group received access to the website and any of three commercially available sensors (a Bluetooth tracker, a GPS location tracker, and a motion sensor). It makes unlikely to mask interventions. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: Intervention components and procedures were not comparable in an unmasked study with participants not blind to interventions and subjective participant‐reported outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "... one participant in the control group was a significant outlier on five of the eight outcome variables; this participant was removed from all analyses." |
| Selective reporting (reporting bias) | Low risk | Comment: There is no available protocol or clinical trial registration number, however the study reports all outcomes described in its method section independently of their significance. |
| Other bias | Low risk | Comment: None detected. |