Dowling 2014.
Study characteristics | ||
Methods |
Design: Parallel randomised controlled trial. No. of participating centres: One, the UCSF Memory and Aging Center. Study dates: Recruitment between July 2011 and March 2012. |
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Participants |
Inclusion criteria: Caregivers needed to reside with and be the primary care provider for a family member with frontotemporal dementia (FTD), speak and read English, have Internet access at speeds consistent with video communication. Exclusion criteria: Caregivers with evidence of severe cognitive impairment or active psychosis. No. of participants randomised to interventions: ‐ Life Enhancing Activities for Family Caregivers (LEAF), (n = 12). ‐ Attention control (n = 12). Baseline characteristics: Caregivers: Mean age for participants was 59.6 years (SD = 8.1). Most caregivers were female (69%), and spousal caregivers (87%). The length of time as a caregiver was 4.2 years (SD = 2.1), The average burden assessed with the ZBI was 47.1 (SD = 13.5). Care recipients: Persons diagnosed with FTD. |
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Interventions |
Experimental: LEAF program delivered across 5 skill‐building sessions with one‐on‐one in‐person sessions with the facilitator (n = 1), or with one‐on‐one Internet video‐conference with the facilitator (n = 11). Control: Five one‐on‐one sessions with the facilitator. The sessions were comparable in length to the intervention sessions but consisted of an interview and did not have any didactic portion of skills practice. Length of intervention: 5 weeks. |
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Outcomes |
Primary outcomes: ‐ Positive and negative affect, assessed with the 20‐item version of the Differential Emotions Scale (DES). ‐ Depresive mood, assessed with the 20‐item Center for Epidemiologic Studies Depression Scales (CES‐D), (range score 0 to 60, higher scores indicate more depressive symptoms). ‐ Caregiver stress, assessed with the 10‐item Perceived Stress Scale (PSS), (scores range from 0 to 40, higher scores indicate greater stress). ‐ Caregiver distress, assessed with the Neuropsychiatric Inventory (NPI), (higher scores indicate greater caregiver distress). ‐ Caregiver burden, assessed with the 22‐item Zarit Burden Interview (ZBI), (scores range from 0 to 88, higher scores denote higher burden). Secondary outcomes: None stated. Outcomes assessment: At 6 weeks (final assessment), and at 10 weeks (follow‐up assessment). |
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Notes |
Clinical trial registration code: NCT01825681. Funding: Grant from the Atlantic Philanthropies Foundation. Conflicts of interest: None declared. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "subjects were randomised to the intervention or control conditions determined by a computer‐generated random number sequence." |
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: Participants and personnel were not blinded to interventions. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: Intervention components and procedures were comparable between study arms, however this is an unmasked study with participants not blind to interventions and subjective participant‐reported outcomes. Moreover, intervention facilitators were not blind to intervention condition. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: Overall, 4 participants of 24 (16.7%) were lost to follow up. |
Selective reporting (reporting bias) | Low risk | Comment: Clinical trial registration NCT01825681 |
Other bias | Low risk | Comment: None detected. |