Lu 2016.
| Study characteristics | ||
| Methods | Randomised controlled pilot study Duration of follow‐up: 3 months |
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| Participants | Country: USA Participants were recruited from the Indiana University Alzheimer Disease Center Clinical Core Registry and Clinic in Indianapolis. Inclusion criteria: participants with dementia: age 60 or older, meeting established mild cognitive impairment (MCI) classification criteria. People with significant neurological disease other than suspected incipient advanced dementia or with current major depression were excluded. Caregiver: adults, primary caregiver responsible for providing unpaid care, MMSE score > 4 (6‐item version) (Ref Callahan, Unverzagt, Hui, Perkins, & Hendrie, 2002). Caregivers diagnosed with bipolar disorder or untreated schizophrenia were excluded. People with dementia and their caregivers had to be able to read and speak English and have access to a telephone. Number of participants completing the study: n = 36 (intervention group n = 17, control group n = 19) Age (mean ± SD) years: participants with dementia: intervention group 71.23 ± 6.84, control group 76.47 ± 7.05; caregivers: intervention group 65.26 ± 7.23, control group 70.47 ± 11.95 Gender, female: participants with dementia: intervention group 40%, control group 45%; caregivers: intervention group 75%, control group 65% Cognitive status, MCI stage: participants with dementia: intervention group: early 40%, late 60%; control group: early 50%, late 50% Relationship to the participant (spouse): intervention group 75%, control group 80% |
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| Interventions | Intervention: Daily Engagement of Meaningful Activities (DEMA) Control: attention control (face‐to‐face meetings providing an overview of study content and an Alzheimer’s Association MCI educational brochure, followed by 4 bi‐weekly social conversation phone calls) |
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| Outcomes | No primary outcome defined. Outcomes assessed: depressive symptoms, life satisfaction (participants with cognitive impairment), caregiver depressive symptoms | |
| Funding | Funded by the National Institutes of Health (NIH) and National Institute of Nursing Research (5R21NR013755‐02; Y.Y.‐F.L.) and in part by NIH O30AG10133 | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Not reported. The authors provided additional information on request: "A random number table was used to generate the randomization sequence (block randomisation stratified on patient’s depression score (Patient Health Questionnaire (PHQ)‐9 ≤ 4 vs PHQ9 ≥5) and stage of MCI (early stage vs late stage)." |
| Allocation concealment (selection bias) | Low risk | Not reported. The authors provided additional information on request: group allocation was performed by an independent biostatistician. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "The interveners (two for each group) were blinded, and all face‐to‐face meetings took place in a private clinical conference room." Methods to increase the implementation fidelity: "standardized training of the nurse interveners and subsequent demonstration of 'satisfactory' intervention delivery skills, including ability to tailor the intervention", "audio recording of intervention and evaluation sessions" "Treatment fidelity for the DEMA and IS sessions were evaluated within 10 days after each session using a quality assurance checklist while listening to the audio tapes." |
| Blinding of outcome assessment (detection bias) Subjective outcomes (participant‐rated) | High risk | Participants and family caregivers (caregiver outcomes) were not blinded to group allocation. |
| Blinding of outcome assessment (detection bias) Subjective outcomes (proxy‐rated) | High risk | Subjective outcomes, and assessors (family caregivers) were not blinded to group allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "Following baseline data collection, 36 of 40 dyads were accrued. The attrition rate was 10%." |
| Selective reporting (reporting bias) | Unclear risk | Trial was not registered, and no study protocol is available. |
| Other bias | Low risk | |