Tremont 2008.

Study characteristics
Methods	Design: Parallel group randomised study. No. of participant centres: One in New England, USA. Study dates: Not reported.
Participants	Inclusion criteria: Caregivers of 21 or older years of age; living with a relative with dementia in the community; and providing a minimum of 4 hours of supervision or direct care per day for at least six months prior to enrolment. Care recipients should had a medical diagnosis of dementia (DSM criteria); a Clinical Dementia Rating (score of 1 (mild) or 2 (moderate); and be aged 50 or older. Exclusion criteria: Presence of a significant psychiatric illness (e.g., schizophrenia, bipolar disorder) or cognitive impairment. No. of participants randomised to interventions: ‐ Family Intervention Telephone Tracking‐Dementia (FITT‐D) (n = 32). ‐ Standard care (n = 28). Baseline characteristics: Caregivers: Mean age for participants was 63.3 years (SD = 11.8), providing an average of 44.3 moths of care (SD = 37.5), with a mean of 18.7 hours/day of care (SD = 7.8). All were spousal caregivers or adult child caregivers. The ZBI mean score for burden was 33.0 (SD = 15.8). Care recipients: Mean age for patients was 75.6 years (SD = 9.9). Mean time since dementia diagnosis was 38.6 months (SD =36.9).
Interventions	Experimental: FITT‐D, a multi‐component intervention delivered in 23 telephone contacts over 12 months. Control: Standard care. Lenght of intervention: 12 months.
Outcomes	Primary outcomes: ‐ Burden (Zarit Burden Interview) (score range 0 to 88, higher scores denote higher burden). ‐ Caregiver depression, assessed by the Geriatric Depression Scale (GDS) (score range 0 to 30, higher scores denote more depressive symptoms). ‐ Caregiver reaction to memory and behavior problems, assessed by the Revised Memory and Behavior Problem Checklist (RMBPC), (score range 0 to 96, higher scores reflect higher levels of perceived caregiver burden). Secondary outcomes: ‐ Caregivers Alzheimer’s Disease Knowledge Test. ‐ Caregivers SF 36 General Health. ‐ Caregivers Self Efficacy Scale. ‐ Family Assessment Device. ‐ Multidimensional Scale of Perceived Social Support. Outcomes assessment: At 12 months
Notes	Clinical trial registration code: Not reported Funding: Grant from the National Institute of Mental Health (MH62561). Conflicts of interest: None declared.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Caregivers were urn randomised to groups to ensure that the two conditions were balanced on dementia severity (Clinical Dementia Rating (CDR) 1 or 2), caregiver gender, and relationship type (spouse versus other)."
Allocation concealment (selection bias)	Unclear risk	Comment: There is no information on allocation concealment throughout the trial..
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: "The research assistant was blind to group membership." Comment: Intervention components and procedures are not comparable what makes blinding of outcome assessment for subjective participant‐reported outcomes highly unlikely even if using blinded research assistants.
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: High and differential attrition. 16 participants of 32 (50%) dropped out from the experimental group, 10 participants of 28 (35.7%) dropped out from the control group.
Selective reporting (reporting bias)	Unclear risk	Comment: There is no trial registration and/or available protocol.
Other bias	Low risk	Comment: None detected.