Table 8.

Randomised Controlled Trials - Counselling Support Roles – Level II Evidence

Article	Sample	Intervention	Control	Outcome measures	Outcomes/Results	Conclusion
Bass et al., 2003 [33] United States of America Not registered	N = 182 primary family caregivers of people with dementia	• N = unknown • Added care consultation telephone intervention with on average 12 direct communication contacts per year to managed care services • Care consultants work with families in a collegial fashion to help identify personal strengths, provide information regarding available community services, facilitate decisions about how to utilise and apply these services and may contact service agencies on behalf of participants	• N = unknown • Received usual managed care services and could independently contact the Association for services other than care consultation.	• Utilisation outcomes – number of hospital admissions, number of emergency department visits, number of physician visits • Caregiver satisfaction with health plan outcomes – indexes of satisfaction • Caregiver Depression and Strain outcomes – similar to CES-D scale	• 86 % follow-up N = 157 • No significant intervention effects for utilisation outcomes – intervention group less likely to have case management visits or use direct care community services • Significantly increased caregiver satisfaction with health plan outcomes when the care recipient had not received a specific dementia diagnosis • Caregivers in the intervention group had greater decreases in reported symptoms of depression • Non-spouses caregivers showed decreases in relationship strain over 12-months while there was no effect on spouse caregivers	Preliminary level II high quality evidence for care consultation over a year period to significantly decrease depression symptoms in caregivers and reduced caregiver strain in non-spousal caregivers
Burns et al., [35] United States of America Not registered	N = 167 caregiver-care recipient dyads	• N = 82 • Enhanced Care: education sessions on behaviour management, 25 pamphlets and 12 additional pamphlets on stress-coping/stress behaviour management • 24-month primary care intervention conducted every 3 months. Behaviour care component but targeted more towards caregiver wellbeing ~ 60 min duration	• N = 85 • Behaviour care: education sessions on behaviour management, 25 pamphlets on behaviour modification • 24-month primary care intervention conducted every 3 months ~ 30 min duration	• Caregiver Outcome Data – General Well-being scale, Center for Epidemiological Studies Depression scale, Revised Memory and Behavior Problems Checklist	• 46 % follow-up data at 2 years • Significant changes in general well-being over time favouring the enhanced care group • Significant changes in CES-D over time for both groups • Significant decrease in Revised Memory and Behaviour Problems Checklist scores over time for both groups	Preliminary level II high quality evidence for an enhanced care program that focused on managing behavioural problems and assisted with coping strategies to significantly improve general wellbeing in caregivers when compared to a behaviour care education intervention.
Brodaty et al., 2009 [38] Australia, United Kingdom, United States Not registered	N = 155 people with Alzheimer’s Disease and their spouses	• N = 79 • All participants received donepezil for 24 months • Standard services: resource information, help in an emergency and routine services at each site • Psychosocial intervention: Five counselling sessions within 3 months and ad hoc counselling for up to 2 years	• N = 76 • All participants received donepezil for 24 months • Standard services as intervention group but no formal structured counselling	• Caregiver depression – Beck Depression Inventory • Social support – Stokes Social Network List • Patient assessment – MMSE, Global Deterioration Scale Alzheimer’s Disease Assessment Scale – cognitive subscale, Alzheimer’s Disease Cooperative Study – Activities of Daily Living and Revised Memory and Behavior Problems Checklist • Time to nursing home admission or death assed using – Cox Proportional Hazards model	• All participant data (N = 155) included in analyses • No difference in times to nursing home placement or time to death between groups	Lack of level II high quality for a 2 year counselling intervention to delay nursing home admission or increase survival until death in people with Alzheimer’s Disease
Clark et al., 2004 [34] United States of America Not registered	N = 121 people with dementia or an indication of memory loss	• N = unknown • Multi-component telephone-based care consultation delivered by one of three staff (two social workers) with on average 10 direct communications per year	• N = unknown • Received usual managed care services and could independently contact the Association for services other than care consultation.	• Memory Problems – Blessed Orientation-Memory-Concentration Test • Utilisation Outcomes – Medical record data • Psychosocial Outcomes – interviews, Center for Epidemiological Studies Depression Scale, four index item of relationship strain, embarrassment and isolation scales developed specifically for the project	• 74 % follow-up data N = 89 • Intervention group participants had significantly decreased feelings of embarrassment and isolation due to memory problems and decreased difficulty coping with memory problems • Intervention group participants with average or greater than average memory difficulties were significantly less likely to have a hospital admission or emergency department visit during in the 12-month study period and were significantly more satisfied with quality of services	Preliminary level II high quality evidence for a 12-month multi-component telephone-based care consultation intervention to significantly reduce feelings of embarrassment and isolation and decrease ‘difficulty in coping’ due to memory problems in people experiencing memory problems or with a diagnosis of dementia. Additional intervention effects were shown for people with more severe impairment.
Eisdorfer et al., 2003 [36] United States of America Not registered	N = 225 caregivers of people with Alzheimer’s Disease	• Resources to Enhance Alzheimer’s Caregiver Health for Telephone-Linked Care (REACH for TLC). 18-months of • Structural Ecosystems Therapy: (structured family therapy intervention for treatment of behaviour problems) N = 75 or • Structural Ecosystems Therapy plus Computer-Telephone Integrated System (information network computer-telephone technology to augment the therapeutic intervention by facilitating linkages of caregivers with their family and supportive resources outside of the home) N = 77	• N = 73 • Minimal Support Control group – bi-weekly phone calls for 6-months and then monthly calls for 12-months (active listening and empathic comments)	• Activities of Daily Living and Instrumental Activities of Daily Living • Caregiver Stress – Revised Memory and Behavior Problems Checklist, State Anxiety Inventory, Center for Epidemiological Studies Depression scale • Satisfaction with Social Support • MMSE	• 6-months 65 % follow-up data; 18 months 68 % • Caregivers in the combined family therapy and technology intervention experience a significant reduction in depressive symptoms at 6-months • At 18-months the combined intervention was significantly effective for Cuban American husband and daughter caregivers	Preliminary level II high quality evidence for a combined family therapy and technology intervention in reducing depressive symptoms in caregivers particular in Cuban American husband and daughter caregivers
Fortinsky et al., 2009 [43] United States of America Not registered	N = 84 family caregivers of people with dementia	• N = 54 • Care Consultation by a Alzheimer’s association chapter with monthly contact for 12-months for family caregivers via telephone (three changes in staff; professions included speech and language specialist and clinical social workers)	• N = 30 • Received identical educational materials to intervention group with details on dementia symptom management and available community services no further attention from study personnel	• Nursing Home Admission • Self-efficacy – symptom management measure and community support service use • Caregiver burden – 22-item Revised Caregiver Burden Scale • Caregiver Depression – Center for Epidemiological Studies Depression inventory • Caregiver physical health – Hopkins Symptoms Checklist • Satisfaction with intervention	• Primary outcome 96 % follow up data, 82 % other dependent variables, 89 % interview data • Family caregivers in the intervention group were less likely to be admitted to a nursing home – however this was not a statistically significant result • There was no statistically significant effect on self efficacy, depressive symptoms, caregiver burden or physical symptoms	Lack of level II high quality evidence for a 12-month care consultation program to significantly lower rates of nursing home admission however there was a trend toward those in the intervention group. There was no significant effect on any secondary outcomes.
Gaugler et al., 2008 [30] United States of America NCT00362284	N = 406 spouse-caregivers of people with Alzheimer’s disease who lived at home	• N = 203 • Enhanced counselling and support by counsellors with advanced degrees in social work or allied professions (six counselling sessions, weekly support groups and ongoing ad hoc counselling) • 9.5 years of data are reported	• N = 203 • Received services provided to all families of patients at the New York University Alzheimer’s Disease Center: no formal counselling	• Nursing Home Admission: interviews • Caregiver Burden – Zarit Burden Interview • Caregiver depression – Geriatric Depression Scale (GDS)	• 95 % data for primary outcome measure • In both models nursing home admission significantly reduced burden and depressive symptoms • Caregiver burden was significantly lower in the intervention group at each point after nursing home admission • Intervention depression scores were significantly lower than usual care scores at all points before nursing home admission with the exception of baseline. This difference was maintained after nursing home admission for approximately 4 months after which the scores were similar for the remainder of the study	Preliminary level II high quality evidence for nursing home admission reducing caregiver burden and depressive symptoms regardless of the intervention. However six sessions of enhanced counselling and readily available ongoing supportive maintenance provided statistically significant longer term benefits compared to usual care.
He’bert et al., 2003 [39] Canada Not registered	N = 144 caregivers of people with dementia	• N = 72 • 15 week psycho-educative program focusing on cognitive appraisal and coping strategies by a health professional experienced in the care of people with dementia. • 15 2-hour weekly group sessions	• N = 72 • Participants were referred to regular support group program offered by the Alzheimer Society or health care organisations in their region	• Interviews baseline and 16 weeks • Frequency of behavioural and memory problems – Revised Memory and Behavior Problem Checklist • Desire to Institutionalise • Zarit Burden Interview • Anxiety – Spielberger State-Trait Anxiety Inventory • Bradburn Revised Affect Scale • Inventory of Socially Supportive Behaviours • Personal Efficacy • Psychological distress – Psychiatric Symptoms Index	• 82 % follow-up data • There was a statistically significant reduction in disruptive behaviours reaction score in the intervention group • Cross-product frequency/reaction differences between groups was statistically significant	Preliminary level II high quality evidence of a 4 month psycho-educative program to significantly reduce caregiver reactions to behaviour problems
Mahoney et al., 2003 [37] United States of America NCT00178165	N = 100 caregivers of people with Alzheimer’s Disease	• N = 49 • Resources to Enhance Alzheimer’s Caregiver Health for Telephone-Linked Care (REACH for TLC). • Twelve months of using a computer-mediated telecommunications system. Interactive voice response system rich with Alzheimer’s information, personal mailbox, bulletin board and activity-respite conversation. • Weekly conversation with counsellor	• N = 51 • Reference booklet with similar content to module 1 of the intervention that provided strategies to manage AD-related disruptive behaviours	• Activities of Daily Living and Instrumental Activities of Daily Living • Caregiver Mastery Scale • Caregiver Stress – Revised Memory and Behavior Problems Checklist, State Anxiety Inventory, Center for Epidemiological Studies Depression scale	• Follow-up: bothersome measure (45 % both groups) depression and anxiety measures (80 % intervention 84 % control) • No overall significant effect on reducing bother scores, depression or state anxiety scores. • Significant decline in bother scores, depressive symptoms and anxious complaints in participants with low-mid mastery at baseline compared to controls • Caregivers who were wives had a significant reduction in the bothersome nature of caregiving compared to controls	Preliminary level II high quality evidence for an automated telecommunications system designed for caregivers of people with Alzheimer’s Disease in reducing bother, depressive symptoms and anxious complaints in caregivers with low mastery and for those who were wives.
Mittelman et al., 2004 [31] United States of America NCT00178165	N = 406 spouse-caregivers of people with Alzheimer’s disease who lived at home	• N = 203 • Enhanced counselling and support by counsellors with advanced degrees in social work or allied professions (six counselling sessions, weekly support groups and ongoing ad hoc counselling) • Data for the first 5 years is presented	• N = 203 • Received services provided to all families of patients at the New York University Alzheimer’s Disease Center: no formal counselling	• Caregiver depression – Geriatric Depression Scale • Severity of dementia – Global Deterioration Scale	• 80 % follow-up data • At 12-months the change in Geriatric Depression Scale Score was statistically significant • The significantly fewer depressive symptoms in the intervention group were sustained for 3.1 years after baseline	Preliminary level II evidence for a short course of intensive counselling and readily available ongoing supportive maintenance in reducing symptoms of depression among caregivers of people with dementia.
Mittelman et al., 2006 [32] United States of America Not registered	N = 406 spouse-caregivers of people with Alzheimer’s disease who lived at home	• N = 203 • Enhanced counselling and support by counsellors with advanced degrees in social work or allied professions (six counselling sessions, weekly support groups and ongoing ad hoc counselling) • Data over an 18-year period are reported	• N = 203 • Received services provided to all families of patients at the New York University Alzheimer’s Disease Center: no formal counselling	• Dates of permanent nursing home placement and of death were monitored during regular follow-up interviews and telephone contacts. Dates of death confirmed with Social Security Death Index	• All data available for primary endpoint; 97.5 % for interviews • The intervention group had significant delays in nursing home placement – 28.3 % reduction compared to controls	Preliminary level II high quality evidence for a short course of intensive counselling and readily available ongoing supportive maintenance in significantly delaying nursing home placement.
Nobili et al., 2004 [40] Italy Not registered	N = 69 people with a diagnosis of dementia and their caregiver	• N = 35 • Structured intervention: one home visit by a psychologist and one home visit by an occupational therapist; information manual and list of contacts	• N = 34 • Free helpline, information rights and legal aspects, how to file forms for economic help and addresses of community services	• Frequency of problem behaviours – SBI-C • Caregiver stress – RSS • MMSE • Basic and Instrumental activities of daily living – ADL and IADL	• 56 % follow-up data for 12-months • Mean problem behaviour score was significantly lower in the intervention group at 12 months • Significant reduction in frequency of delusions and psychic agitation at 12-months in the intervention group	Preliminary level II high quality evidence for a structured intervention (on two occasions) in reducing frequency of problem behaviour particularly delusion and psychic agitation in people with dementia
Teri et al., 2003 [41] United States of America Not registered	N = 153 community dwelling people with Alzheimer’s Disease	• N = 76 • Exercise program and behavioural management and education program for caregivers by clinical geropsychologists and a physical therapist • 12 h long sessions over an 11 week period, then three follow up sessions over 3 months	• N = 77 • Routine medical care including acute medical or crisis intervention provided at community health care centres	• Physical health and function – SF-36and Sickness Impact Profile • Affective status – Hamilton Depression Rating Scale, Cornell Scale for Depression in Dementia • Physical Health tests • Patient behavioural disturbance and caregiver distress – Revised memory and Behavior Problem Checklist	• 92 % completed post-test assessment; 58 % completed 24-month assessment At 3 months: • Statistically significant improvement in SF-36 and Cornell depression scores At 24 months: • Statistically significant differences between groups on the SF-36 physical role functioning subscale and the SIP Mobility Scale Additional Analysis • People with higher depression scores at baseline improved significantly more at 3-months on the Hamilton Depression Rating Scale and maintained this at 24 months.	Preliminary level II high quality evidence for 6-month exercise training combined with teaching caregivers behavioural management techniques to improve physical health in people with Alzheimer’s Disease
Wray et al., 2010 [42] United States of America NCT00105638	N = 158 spousal caregivers of people with dementia	• N = 83 • Telehealth Education Program delivered by trained group leaders (social workers and nurse dementia care manger) to groups of up to 8 caregivers for 1 h every 10 weeks	• N = 75 • All usual services that Veteran Affairs provides expect for the Telehealth Education Program	• Veteran Health Care Cost and Utilisation Data	• All data included - intention to treat • Significant short-term effect (6-month) on total cost and nursing home cost with a decrease in overall cost of care per patient decreasing in the intervention group compared to the control	Preliminary level II high quality evidence for a 10-week Telehealth Education Program in producing significant short-term decreases in overall and nursing home cost of care for people with dementia