Martindale‐Adams 2013.
Study characteristics | ||
Methods |
Design: Parallel randomised study. No. of participating centres: One, Veterans Affairs Medical Center, Memphis, Tennessee, USA. Study dates: October 2004 to September 2007. |
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Participants |
Inclusion criteria: Caregivers reporting stress or difficulty with care, living with care recipient, and providing 4 or more hours/day of supervision or care for at least 6 months. Care recipients had a dementia diagnosis or MMSE score of 23 or less and at least 1 ADL or 2 IL limitations. One member of the dyad had to be a veteran receiving services at VAMC Memphis. Exclusion criteria: Planned nursing home admission within 6 months. No. of participants randomised to interventions: ‐ Telephone Support for Dementia Caregivers (n = 77). ‐ information alone (n = 77). Baseline characteristics: Caregivers: Mean age for participants was 65.6 years (SD = 12.4). Most caregivers were female (83.7%). The mean length of time caregiving was 48.9 months (SD = 38.5). The mean caregiving hours on duty was 16.4 (SD = 8.6), and the mean caregiving time was 6.5 hours/day (SD = 4.9). The mean score for burden was 17.05 (SD = 8.7). Care recipients: Mean age for patents was 77.4 years (SD = 7.4), and most were male (87.6%). The mean MMSE score was 15.4 (SD = 7.5). |
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Interventions |
Experimental: Telephone Support for Dementia Caregivers included 12 individual in‐home and telephone sessions and 5 telephone support group sessions. The support groups met bi‐weekly for 2 months and monthly thereafter for 1 year, for a total of 14 hour‐long sessions. The sessions were semi‐structured telephone calls with education, skills‐building, and support. Control: Control caregivers received pamphlets on dementia and safety and information for local resources. Length of intervention: 12 months. |
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Outcomes |
Primary outcomes: ‐ General health, assessed with one question from the SF‐36. ‐ Caregiver burden, assessed with the ZBI scale (12‐item), (score range 0 to 48, higher scores denote greater burden). ‐ Depression, assessed by the CES‐D scale, (score range 0 to 30, higher scores denote more depressive symptoms). ‐ Overall mental health, assessed by the General Well‐Being Scale 22‐item (scoring is 1 = definitely true, all of the time to 5 = definitely false, not at all; higher scores indicate greater well‐being). ‐ Bother, assessed with the RMBPC scale (score range 0 to 96, higher scores represent higher perceived burden). ‐ Care recipient health, assessed with one question from the SF‐36 (1 = poor to 5 = excellent). Secondary outcomes: None stated. Outcomes assessment: At 6 (intermediate assessment), and 12 months (final assessment). |
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Notes |
Clinical trial registration code: NCT00119561. Funding: Veterans Health Administration, Health Services Research and Development Service (IIR‐03‐287‐1), US Department of Veteran Affairs; and Memphis Veterans Affairs Medical Center. Conflicts of interest: None declared. Fidelity / adherence: 61% of participants took part in at least 75% of the support group sessions of the program. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: Study described as randomised but there is no information on the randomization procedure. |
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: Interventions cannot be blinded. Study described as open trial in the protocol. |
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 | Low risk | Comment: There is a low attrition rate and similar between groups: 8 participants of 77 (10.4%) were lost to follow up in the intervention group, 7 participants of 77 (9.1%) were lost to follow up in the control group. |
Selective reporting (reporting bias) | Low risk | Comment: Clinical Trials Identifier: NCT00119561. |
Other bias | Low risk | Comment: None detected. |