Duggleby 2018.
Study characteristics | ||
Methods |
Design: Randomised parallel trial. No. of participating centres: Multicenter. Study dates: June 2015 to April 2017. |
|
Participants |
Inclusion criteria: Carers (18+ years) of community‐living care recipients with Alzheimer's disease and related dementia (ADRD) and two or more chronic conditions, and 65+ years. Carers were all English speaking and either a family or fried of the care recipient, with access to a computer and a valid email address Exclusion criteria: Non‐English speaking carers; care recipient under the age of 65 years, who did not have ADRD and chronic conditions, or who was not a community‐living care recipient. No. of participants randomised to interventions: ‐ My Tools 4 Care (MT4C) (n=101). ‐ Educational control group as usual care (n=98). Baseline characteristics: Caregivers: Mean age was 63.6 years (SD=11.6), 81% were female (161 of 199), most were spouse or partners (189 of 199, 95%), with a mean duration of care of 4.3 years (SD=4.2). Care recipients: Mean age was 80.3 years (SD=7.7), most were males (104 of 199, 52%). |
|
Interventions |
Experimental: MT4C is a Web‐based intervention intended to support carers . Control: Educational group Length of intervention: 3 months. |
|
Outcomes |
Primary outcomes: ‐ mental component summary score (MCS) from the SF‐12v2. Scores range from 0 to 100, with higher scores indicating a better health‐related quality of life. Secondary outcomes: ‐ physical component summary score (PCS) from the SF‐12v2. Scores range from 0 to 100, with higher scores indicating a better health‐related quality of life. ‐ General Self‐Efficacy Scale (GSES). Total scores range from 10 to 40, with higher scores indicating a greater level of self‐efficacy. ‐ Herth Hope Index (HHI). Total scores range from 12 to 48, with higher scores indicating a greater hope. ‐ Health and Social Services Utilization Inventory (HSSUI). Outcomes assessment: At 3 and 6 months after baseline. |
|
Notes |
Clinical trial registration code: NCT02428387. Funding: Canadian Institutes of Health Research (TTF 128261). Conflicts of interest: No competing interests declared. Fidelity / adherence: Authors report that 73% of caregivers used the intervention at least once over the 3‐month intervention period. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A biostatistician...generated group allocations using stratified permuted block randomization". |
Allocation concealment (selection bias) | Low risk | Quote: "Random number sequences were fed... into RedCap, a secure, password‐protected Web‐based randomization service... which allocated clients to the two groups according to a random sequence". |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Given the nature of the study, the research team was unblinded to group allocation". |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: Data collection forms were emailed to participants following the first interview. However, outcomes were participant‐reported and intervention components and procedures were not comparable. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: intention‐to‐treat principles were used in all analyses. However, randomised groups presented differential attrition; at 3‐month 23 participants of 101 (23%) were lost to follow‐up in the intervention group whereas 9 participants of 98 (9%) were lost in the comparison group. Rates at 6‐month follow‐up were 27% (28/101) and 17% (17/98) respectively. |
Selective reporting (reporting bias) | Low risk | Comment: study is registered (NCT02428387) and protocol published (Duggleby 2017). Reported outcomes agree with those described in registry and protocol. |
Other bias | Low risk | Comment: none detected. |