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. 2021 Jan 4;2021(1):CD006440. doi: 10.1002/14651858.CD006440.pub3

Gant 2007.

Study characteristics
Methods Design: Parallel group randomised study.
No. of participant centres: One. Missouri, USA.
Study dates: Not reported.
Participants Inclusion criteria: Primary caregivers (men) for a family member diagnosed with dementia; living in same residence as care recipient; caregiver between ages of 30 and 85; no plans to place the family member in a nursing home or hospital services within the next 6 months; visual acuity sufficient to read a book; auditory ability to hear voice on the telephone and TV; access to telephone, TV, and VCR; an established relationship with a clinic or primary care physician with whom caregiver had visited within the last year; at least 2 care recipient memory or behavior problems that occurred in the past week, and at least a moderate level of distress (upset or annoyance) following 2 or more care recipient behaviours.
Exclusion criteria: Current alcohol abuse or serious suicidal ideation; history of suicide attempt; no current involvement in another caregiver intervention project.
No. of participants randomised to interventions:
‐ Video intervention (video/workbook/telephone coaching condition) (n = 17).
‐ Educational booklet, check‐in‐call condition (n = 15).
Baseline characteristics:
Caregivers: Mean age for participants was 71.6 years (SD = 9.7). All caregivers were men and most were spouse (88%).
Care recipients: Mean age for patients with dementia was 76.1 years (SD = 7.6).
Interventions Experimental (video/workbook/telephone coaching condition): Participants received a 10‐session video series, a workbook adapted for men from the Dementia Caregiving Skills Program, and 12 weekly telephone calls from a trained coach.
Control (education/check‐in‐call condition): Participants received by mail a 37‐page booklet, Basic Dementia Care Guide, which included information on dementia and suggestions for dealing with a variety of caregiving challenges. Caregivers then received approximately 7 biweekly telephone calls by a trained staff member.
Length of intervention: 12 weeks.
Outcomes Primary outcomes:
‐ Memory and behavior problems, assessed by the RMBPC scale (score range 0 to 96, higher scores reflect higher levels of perceived caregiver burden).
‐ Self‐efficacy, assessed by the 15‐item Revised Scale for Caregiving Self‐ Efficacy (score range 0 to 100, higher scores denote more self‐efficacy).
‐ Positive and negative emotions of the caregiver, assessed by the Positive and Negative Affect Scale (score range 10 to 50, higher scores denote either more positive or negative emotions).
‐ target complaints interview (3 most upset situations assessed with a Likert scale (1: slightly or not at all, 5: extremely).
Secondary outcomes: None stated for the caregiver.
Outcomes assessment: At 12 weeks.
Notes Clinical trial registration code: Not reported.
Funding: Grants from the Missouri Alzheimer’s Disease and Related Disorders Research Board, and the National Institute of Mental Health.
Conflicts of interest: None declared.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: Use of an online random number generator, Research Randomizer available at randomizer.org (information provided by authors).
Allocation concealment (selection bias) Low risk Comment: The randomization sequence was concealed for project coordinator (information provided by authors).
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 Quote: "Assessment interviews were conducted by the trained project staff who were blind to condition".
Comment: However, intervention components and procedures were not comparable wit participants not blind to intervention and subjective participant‐reported outcomes.
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "Of the 32 randomised caregivers, 4 did not complete the program; all 4 of these withdrawals were from the video group. Reasons for withdrawal included insufficient interest and time (n = 3), as well as nursing home placement of the care recipient (n = 1). For the purposes of outcome analyses, an intent‐to‐treat approach (pre‐intervention scores carried forward) was used to handle the missing data."
Selective reporting (reporting bias) Unclear risk Comment: There is no available protocol or clinical trial registry.
Other bias Low risk Comment: None detected.