Metcalfe 2019.
| Study characteristics | ||
| Methods |
Design: Parallel randomised controlled trial. No. of participating centres: International multicenter trial including three centres: Klinikum rechts der Isar, München, Germany; Université Pierre et Marie Curie, Paris, France; Bradford School of Dementia Studies, Bradford; UK. Study dates: First enrolment in the year 2016. |
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| Participants |
Inclusion criteria: Primary informal carers of patients with dementia in Alzheimer's disease or behavioural‐variant frontotemporal dementia and an onset before the age of 65 years; age over 18 years; basic computer literacy and access to computer and the Internet. Exclusion criteria: Carers of people with other dementia. No. of participants randomised to intervention: ‐ RHAPSODY programme immediate access (n=30). ‐ Wait‐list control (n=30). Baseline characteristics: ‐ Caregivers: Mean age 57.4 years (SD=10.1), 61% females, mean caregiving years 2.2 (SD=1.5). ‐ Care recipients: Mean age 61.7 years (SD=4.9), 49% females. |
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| Interventions |
Experimental: Web‐based e‐learning programme (RHAPSODY). Control: Standard treatment (usually one single counselling session), wait‐list control group. Length of intervention: 6 weeks. |
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| Outcomes |
Primary outcomes: ‐ Self‐efficacy assessed with the Revised Scale for Caregiving Self‐Efficacy (RSCSE). ‐ Disease‐related knowledge assessed with the Coping with the Caregiving Role Questionnaire, self‐designed. Secondary outcomes: ‐ Stress assessed with the Perceived Stress Scale (PSS). ‐ Health‐related quality of life (EuroQol EQ‐5D‐5L). ‐ Caregiver burden assessed with the Burden Scale for Family Caregivers (BSFC). ‐ Patient symptoms assessed with the REvided Memory and Behaviour Checklist (RMBC). ‐ Technology acceptance assessed with the Technology Acceptance Model (TAM) adapted. Outcomes assessment: At 6 weeks and at 12 weeks (when wait‐list control have crossed to e‐learning for 6 weeks). |
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| Notes |
Clinical trial registration code: DRKS00009891. Funding: Public grants from German, French, and UK agencies. Conflicts of interest: None declared. Other: Care recipients present early‐onset dementia (onset of symptoms before the age of 65 years). |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Computer‐generated randomization and closed envelopes were used to assign participants to group A (immediate access to the online programme) or group B (wait‐list control with delayed access to the programme)." |
| Allocation concealment (selection bias) | Low risk | Quote: "Computer‐generated randomization and closed envelopes were used to assign participants to group A (immediate access to the online programme) or group B (wait‐list control with delayed access to the programme)." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: Unblinded study as reported by authors. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: There is no information on blinding of outcome assessors. This is an unmasked study with participants not blind to interventions and subjective participant‐reported outcomes, with components and intervention procedures not comparable. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: Three participants (one at each intervention site) of 61 dropped out during the study. |
| Selective reporting (reporting bias) | Low risk | Comment: There is a clinical registration number and protocol. All prespecified outcomes are reported. |
| Other bias | Low risk | Comment: None detected. |