Winter 2007.
Study characteristics | ||
Methods |
Design: parallel group randomised trial. No. of participant centres: A service organization, Supportive Older Women’s Network, and an academic research centre in Philadelphia; USA. Study dates: Not reported. |
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Participants |
Inclusion criteria: Female caregivers, 50 years of age or older, providing care for a minimum of 6 months to a relative with a physician’s diagnosis of ADRD, and having weekly access to a telephone for at least 1 hour. Exclusion criteria: Male caregivers. No. of participants randomised to interventions: ‐ Telesupport (n = 58). ‐ Usual care (n = 45). Baseline characteristics: Caregivers: Mean age for participants was 66.6 years (SD = 9.1), a 42% were spouses of care recipients. Average years of caregiving were 4.4 (SD = 4.0). Caregivers presented a CES‐D score of 15.1 (SD = 10.9). Care recipients: Mean age for patients was 80.2 years (SD = 9.1). |
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Interventions |
Experimental: Telesupport treatment; professionally led telephone‐based support groups conducted by trained social workers who used conference‐ calling technology service to link 5 caregivers per group for an hour weekly. Caregivers used their own telephones with no charge. Control: Usual care, control group. Lenght of intervention: 6 months. |
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Outcomes |
Primary outcomes: ‐ Caregiver depression, assessed by the 20‐item Centers for Epidemiological Studies–Depression Scale (CES‐D), (score range 0 to 30, higher scores denote more depressive symptoms). ‐ Caregiver burden, assessed by the 22‐item Zarit burden scale, (score range 0 to 88, higher scores denote higher burden). ‐ Personal gains, were measured with a 6‐item scale adapted from Kaye’ Gain Through Group Involvement Scale, (score range 6 to 18, higher scores represent more personal gain). Secondary outcomes: None stated. Outcomes assessment: At 6 months. |
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Notes |
Clinical trial registration code: Not reported Funding: Funds from the Alzheimer’s Association. Conflicts of interest: None declared. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: Study reported as randomised but without information on the randomization procedure. |
Allocation concealment (selection bias) | Unclear risk | Quote: "The Supportive Older Women’s Network was notified of caregivers randomised to intervention and contacted caregivers to enrol them in a group." |
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 not comparable. This and the unblinded participants and subjective participant‐reported outcomes makes blinding outcome assessments highly unlikely. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: There is no data on attrition by treatment arms. Overall, 22 participants of 103 (21.4%) dropped out. |
Selective reporting (reporting bias) | Unclear risk | Comment: There is no trial registration and/or available protocol. |
Other bias | High risk | Comment: There is an imbalance in numbers randomised (58 to experimental group, 45 to control group), and differences in age at baseline (participants randomised to experimental group are older, about a mean of 5 years, than those randomised to control group). |
AAL: Active Assisted Living; AD: Alzheimer Disease; ADKS: Alzheimer’s Disease Knowledge Scale; ADL: Activities of Daily Living; ADRD: Alzheimer’s Disease and Related Dementias; BA: Behavioral activation; BDI: Beck Depression Inventory; BDI: Beck Depression Inventory; BSFC: Burden Scale for Family Caregivers; CA: California; CCS: Caregiver Competence Scale; CDR: Clinical Dementia Rating; CES‐D: Center for Epidemiological Studies – Depression scale; D‐CHESS: Dementia–Comprehensive Health Enhancement Support System; DES: Differential Emotions Scale; DRS: Dyadic Relationship Scale; DSM: Diagnostic and Statistical Manual; DVD: Digital Versatile Disc; EOC: Education Only Condition; EQ: EuroQol; ESBR‐m: Education and Skill Building Rehabilitation‐mobile ; FAS: family Assessment Service; FITT‐C: Family Intervention Telephone Tracking‐Caregiver; FITT‐D: Family Intervention Telephone Tracking‐Dementia; FTD: Frontotemporal Dementia, GDRS: Geriatric depression Rating scale; GDS: Global Deterioration Scale; GPS: Global Positioning System; GSES: General‐Self‐Efficacy Scale; HADS‐A: Hospital Anxiety and Depression Scale‐ anxiety; HADS: Hospital Anxiety and Depression Scale; HHI: Herth Hope Index; HSSUI: Health and Social Services Utilization Inventory; ICC: iCare Condition; ICD: International Statistical Classification of Diseases and Related Health Problems; ICT: Information and Communication technology; IESS: Instrumental and Expressive Social Support Scale; IQ; CODE: Informant Questionnaire on Cognitive Decline in the Elderly; ISEL: Interpersonal Support Evaluation List; ITT: Intention to treat ; IVR: Interactive Voice Response; LEAF: Life Enhancing Activities for Family; LSI‐Z: Life Satisfaction Inventory‐Z; MCS: Mental Component Summary; MMSE: Mini Mental State Examination; MoD: Mastery over Dementia; MT4C: My Tools 4 care; NHP: Nottingham Health Profile; NIH: National Institutes of Health; NINCDS‐ADRDA: National Institute of Neurological and Communicative Disorders and the Alzheimer`s Disease and Related Disorders Association; NPI: Neuropsychiatric Inventory; PAC: Positive aspects of caregiving; PQoL: Perceived Quality of Life; PSS: Perceived stress scale; PsyED: Psychoeducation; QoL: Quality of Life; QOLS: Quality of life Scale; RCSE: Revised Scale for Caregiving Self‐Efficacy; RCSS: Revised Caregiving Satisfaction Scale; REACH: Resources for Enhancing Alzheimer's Caregiver Health; RMBPC: Revised Memory and Behavioral Problem Checklist; RSCS: Revised Scale for Caregiving Self‐Efficacy; SCB: Screen for Caregiver Burden; SD: standard deviation; SEQ: Self‐efficacy Questionnaire; SF: Short Form; SPPIC: Self‐perceived Pressure from Informal Care Scale; SSCQ: Short Sense of Competence Questionnaire; STAI: State ‐Trait Anxiety Inventory; STAR: Skills Training and Reskilling; TAM: Technology Acceptance Model; TBA: Telephone behavioral activation; TGM: Telephone general monitoring; TLC: Telephone‐Linked Care; TOA: Trust in Own Abilities; TV: Television; UCSF: University of California, San Francisco; UK: United Kingdom; USA: United States of America; VA: Veterans Affairs; VCR: videocassette recorder; VU: Vrije Universiteit; ZBI: Zarit burden interview.