[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Eligibility criteria for informal caregivers included thefollowing: age 21 years or older; living with or sharingcooking facilities with the care recipient; providing carefor a relative with a medically diagnosed Alzheimer’s dis-ease (AD) or related disorders, vascular dementia (VD)or behavior variant frontotemporal dementia (bvFTD)for at least 4 h per day for at least the past 6 months; in-formal caregiver speaks fluent German.
Excluded criteria: We excludedcaregivers who were involved in another caregiver inter-vention study, who had an actual psychiatric diagnosis ofmental illness or another illness that would prevent6 months of study participation, or the forthcoming institutionalization of the person being cared for.
Pretreatment: The baseline characteristics of the informal caregivers and relatives with dementia are presented in Table 1.Informal caregivers in the intervention group showed significantly more somatization, lower psychological health-related quality of life, and stronger reaction in response to the challenging behaviors of the people withdementia than informal caregivers in the control group.There was also a trend for informal caregivers in the intervention group to be more depressed.
Intervention Characteristics
Intervention
Control
BPSD (revised memory an behavior problem checklist (disruptive) SD. Change
Caregivers burden (ZBI revised 22 item), SD
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Included criteria: The inclusion criteria for familycaregivers included being 18 years orolder and living with and caring for arelative who was diagnosed as having a type of dementia caused byAlzheimer’s disease, according toDSM-IVcriteria.
Excluded criteria: Caregivers who had mental illness themselves or whohad cared for their family member for less than three months were ex-cluded.
Pretreatment: There were no differences between the study groups with respect to their sociodemographic characteristics, types and dosages of medications, or mean scores on the baseline measures when Student’s t tests or chi square tests were used
Intervention Characteristics
Intervention
Control
BPSD (NPI), SD
Caregivers burden (familiy caregiving burden inventory), SD
Institutionalisation, SD
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Included criteria: SampleThe participants in this study were family members caring fora relative with dementia at home, and they were recruitedfrom the two largest dementia resources centres, which hadabout 1500 clients primarily diagnosed with dementia,representing 8% of this client population in Hong Kong(Hospital Authority, Hong Kong 2006). Participants wereeligible for inclusion if:•They were aged at least 18 years and could speak and readChinese;•They lived with a relative who was diagnosed as having theAlzheimer’s type of dementia (mild or moderate illnessstage) according to the criteria of the Diagnostic and Sta-tistical Manual of Mental Disorders, 4th edition (AmericanPsychiatric Association 1994), and they provided care forat least 4 hours per day; and•Their relative suffered no co-morbidity of other mentalillness during the recruitment period.
Excluded criteria: They were excluded if they themselves had mental illnessand/or cognitive impairment, or if they had been the primarycarer for3 months.
Intervention Characteristics
Intervention
Control
BPSD (NPI), SD
Caregivers burden, (Caregiver Burden Inventory) SD
Institutionalisation, SD.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: To participate in the study, caregivers had to bethe primary caregivers and report at least onelimitation in basic activities of daily living (ADLs;Katz, Ford, Moskowitz, Jackson, Jaffe, 1963) ortwo dependencies in instrumental activities of dailyliving of the care recipient (IADLs; Lawton Brody,1969). Additionally, caregivers had to be at least 21years of age, have been caregiving for at least 6 months, and provide at least 4 hr of care each day.
Excluded criteria: Caregivers were not eligible if they did not live withthe care recipient, were undergoing chemotherapy orradiation therapy for cancer, had more than threehospitalizations in the past year, or were planning toplace the care recipient in a nursing home within thenext 6 months.
Intervention Characteristics
Intervention
Control
BPSD (Revised version of RMBP, disruption-related), SD
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: The inclusion criteria for the present study were asfollows: very mild (Clinical Dementia Rating globalscore [CDR]=0.5) or mild (CDR=1.0) AD at baselineas diagnosed by specialists, the ability to speak and un-derstand Finnish, community-dwelling, free of comor-bid conditions that could have affected cognition atbaseline, capable of performing the CERAD-NB, andthe presence of a family caregiver (Karttunenet al.,2011; Hallikainenet al., 2012; Välimäkiet al., 2014.)
Intervention Characteristics
Intervention
Control
BPSD (NPI), SD
Institutionalisation
Quality of life (Qol-AD), SD
Caregivers burden (GHQ), SD
ADL (ADCS-ADL), SD
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control 1
Control 2
Included criteria: The inclusion criteria were: patients had to satisfy DSM-III-R on criteria were: primary degenerative dementia of the Alzheimer type and be living in the community with a carer who provided their main support; and the carer had to achieve psychiatric caseness with a score on the General Health Questionnaire score on the General Health of 5 or above, indicating significant psycho-or above, indicating significant psychological morbidity.
Intervention Characteristics
Intervention
Control 1
Control 2
BPSD (MOUSE-PAD), SD
Depression (Cornell scale for depression dementia), SD
Caregivers burden (GHQ), SD
ADL, SD
Data obtained from:
Jensen M, Agbata IN, Canavan M, McCarthy G. Effectiveness of educational interventions for informal caregivers of individuals with dementiaresiding in the community: systematic review and meta-analysis of randomised controlled trials. Int J Geriatr Psychiatry. 2015 Feb;30(2):130-43. doi: 10.1002/gps.4208.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Included criteria: Persons with dementia and their families were re-cruited from local memory loss clinics, the GeriatricResearch, Education, and Clinical Center at the Min-neapolis Veterans Hospital, other senior clinics and healthcenters, the Minneapolis/St. Paul Alzheimer's Associa-tion, and local community hospitals and health andsocial service agencies. To be enrolled in the study,families needed to be caring for a person with a diag-nosis of nonreversible dementia who1. Was living in the community.2. Demonstrated signs of mild to severe dementia;only those who were nonambulatory and requiredtotal care (judged to be at or below a telephone-administered Functional Assessment Staging Test[Reisberg, 1988] score of 7b) were excluded.3. Displayed behavior problems (as perceived by thecaregiver).4. Was able to accompany the caregiver to at leastthe first two weekly intervention sessions.In addition, at least one additional family member,other than the primary caregiver, needed to be will-ing to accompany the caregiver ancTpatient to sevenweekly sessions
Intervention Characteristics
Intervention
Control
BPSD (Revised memory and behavior problem checklist), SD
Caregivers burden (ZBI revised), SD
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: All patients with a diagnosis of probable or possible AD, acoording to NINCDS-ADRDA criteria, with a known primary caregiver who was responsible for providing informal care to the patient.
Excluded criteria: Patients affected by other kinds of dementia or included in other non-pharmacological intervention trials and/or in pharmacological clinical trials were excluded. Patients who informal caregiver was unable or refused to participate were excluded.
Intervention Characteristics
Intervention
Control
Caregivers burden (caregivers burden inventory), SD
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Included criteria: The inclusion criteria of family caregivers were those who were aged‡18 years and living with and caring for the client diagnosed as Alzheimer’s type of dementia according to the DSM-IV (American Psychiatric Association, 1994).
Excluded criteria: Those who had a mental illness themselves or cared for their patientless than two months were excluded.
Intervention Characteristics
Intervention
Control
Institutionalisation, SD
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Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Quote: "We used a central randomization via randomization lists realized by an on- line procedure of the Medical Faculty of the Ludwig Maximilians University of Munich [20]."
Quote: "total of 88 of 200 pairs of eligible patients and their primary caregivers were selected randomly from a list of patients who attended one of the two dementia centers."
Judgement Comment: Insufficient information on sequence generation
Quote: "After completion of the baseline measures, the participants were randomly assigned to either the DFCP or routine family support services (control group)."
Judgement Comment: Insufficient information on sequence generation
Quote: "The randomization schedule used random permuted blocks within each stratum and was prepared by the site biostatistician. Randomization was accomplished by opening opaque sealed envelopes in sequential order for the appro- priate stratum."
Quote: "The list of randomization numbers and the group sta- tus was created using the computer algorithm, and the study nurse who otherwise took no part in the study in- formed both the participants and the rehabilitation center."
Quote: "Subjects were allocated to one of three Subjects were allocated to one of three groups ± the family intervention group or groups ± the family intervention group or one of the two control groups ± by means one of the two control groups ± by means of random number tables independent of of random number tables independent of the assessor and clinician."
reference: Jensen et al., 2015
Quote: "Once these were done, each family was randomly assigned by a computer program to one of two groups (each family had an equal chance of assignment to either group)."
Judgement Comment: Assigned through computer-generated random numbers
Quote: "Eighty of 400 pairs of eligible patients and their primary family caregivers were selected randomly from the client list of the centre, using the computer-generated random numbers. They were then ran- domly assigned into either the FMSP-DC or routine care group (control), each consisting of 40 family dyads."
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Quote: "To obtain the same number of subjects in the intervention and the control group, we used a randomized block design [21]."
Quote: "In order to conceal the inter- vention of interest for family care- givers, six monthly education sessions on dementia care were provided to the standard care group."
Judgement Comment: Insufficient information on allocation concealment
Quote: "The randomization schedule used random permuted blocks within each stratum and was prepared by the site biostatistician."
Quote: "The list of randomization numbers and the group sta- tus was created using the computer algorithm, and the study nurse who otherwise took no part in the study in- formed both the participants and the rehabilitation center. The intervention was provided during the first 2 years"
Judgement Comment: Insufficient information on allocation concealment
reference: Jensen et al., 2015
Judgement Comment: Insufficient information on allocation concealment
Judgement Comment: Code as assigned to caregiver and an envelope corresponding to treatment was given.
Judgement Comment: Insufficent information on allocation concealment
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Judgement Comment: Insufficient information on blinding of participants and personnel
Judgement Comment: Insufficient information on blinding of participants and personnel
Judgement Comment: Insufficient information on blinding of participants and personnel
Judgement Comment: Insufficient information on blinding of participants and personnel
Judgement Comment: Only mentioned as a rater-blinded study
Judgement Comment: Insufficient information on blinding of participants and personnel
reference: Jensen et al., 2015
Judgement Comment: Insufficient information on blinding of participants and personnel
Judgement Comment: Insufficient information on blinding of participants and personnel
Judgement Comment: Insufficient information on blinding of participants amd personnel
Detection bias due to knowledge of the allocated interventions by outcome assessors
Quote: "The outcome rater was not informed about the randomization code of a participant before opening a sealed envelope with the code inside after completion of the baseline assessment."
Quote: "One researcher who was blind to the group assignment administered the pretest before randomization and the two posttests at six and 12 months after the start of the intervention."
Quote: "A research assistant, who was blind to the subject assignment, administered the pretest before randomization (Time 1), and asked the participants again to complete the outcome measures, including caregivers’ bur- den, quality of life, social support, use of family services and client symptom severity scales, for three post-tests at 1 week (Time 2), 12 months (Time 3) and 18 months (Time 4) following the intervention. The"
Judgement Comment: Insufficient information on blinding of outcome assessors
Quote: "Another study nurse and a psychologist carried out annual follow-up tests and interviews. They were both blinded to the randomization group and did not partici- pate in providing common health care."
Judgement Comment: Insufficient information on blinding of outcome assessors
reference: Jensen et al., 2015
Quote: "The workshop faculty had no way of knowing the study status (immediate or waiting list) of workshop participants, except in the first two and the last workshops."
Judgement Comment: The study was designed as a PROBE (Prospective randomized Open, Blinden Endpoint)
Quote: "One researcher who was blind to the group assignment administered the outcome measures, including caregivers’ burden (Family Caregiving Burden Inventory; Chou, Jiann- Chyun & Chu 2002), quality of life (WHOQOL-BREF; Leung et al. 1997) and social support (Six-item Social Support Questionnaire; Sarason et al. 1987) at baseline before randomisation and at post-test at one week after intervention. The"
Attrition bias due to amount, nature or handling of incomplete outcome data
Quote: "Several methods with missing value imputation were used, including expectation maximization method and the multiple imputations strategy implemented in the Statis- tical Packages for Social Sciences (SPSS) software version 20.0. Secondary analyses of the primary outcome variable were performed on patients treated per protocol (PP population). Secondary"
Judgement Comment: Dropput accounted for and equivalent across groups
Quote: "The data analysis used an intention-to-treat design that maintained the advantages of ran- dom allocation (15). In"
Judgement Comment: However the 5% dropout in the intervention group were not specified.
Quote: "Analysis of data was on an intention-to-treat basis, thus maintaining the advantages of random sampling and enhanc- ing the validity of the study findings (Montori & Guyatt 2001). Repeated-measures"
Judgement Comment: No apperent sources of bias
Quote: "rate. Twenty subjects were bereaved, 16 had placed their family member in a long-term care facility, 24 missed the follow-up interview, and 7 had dropped out of the study. In accordance with clinical trial research principles, to reduce the number of subjects with missing data, we interpolated scores for 2 subjects who were unavail- able at the 6-month follow-up but participated in the 12-month follow-up interview. The difference be- tween the 12-month follow-up and baseline values was divided by time between follow-up and baseline to obtain a difference per day. This value was then multiplied by 182 (the number of days in 6 months)"
Judgement Comment: There were 30 out of 84 that dropped out in the intervention group (36%).There were 76 out of 152 that dropped out in the control group (50%).There were no statistical analysis that accounted for inclompete outcome data.
Quote: "One patient and allocated to each group. One patient and carer dropped out of the intervention and carer dropped out of the intervention and were lost to the study. The"
Judgement Comment: No apperent sources of bias
reference: Jensen et al., 2015
Quote: "Twelve families discontinued participation in the immediate intervention group (16%) and 11 fami- lies dropped out of the waiting list control group (26%). The dropouts and completers (both intervention and waiting list control groups combined) were compared on the basis of their baseline scores on the study's major outcome variables (i.e., caregiver's perception of disruptive behaviors, caregiver's reaction to disrup- tive behaviors, caregiver burden, and caregiver depres- sion). The two groups were also compared on the basis of demographic variables of caregiver and patient age, caregiver and patient education, caregiver and patient gender, and caregiver and patient income. With the exception of patient age, none of the differences was"
Judgement Comment: No apparent sources of bias
Judgement Comment: Dropouts accounted for and equivally distributed among groups.Intention-to treat analysis: multiple imputation method for missing data.
Quote: "Data analysis used an intention-to-treat basis that maintained the advantages of random allocation."
Judgement Comment: No apparent sources of bias
Reporting bias due to selective outcome reporting
Quote: "Clinical trial registration: NCT01690117. Registered September 17, 2012."
Judgement Comment: Matches study protocol and the study appears to be free of selective outcome reporting
Judgement Comment: No reference to study protocol, but appears to be free of selective outcome reporting
Judgement Comment: No reference to study protocol, but appears to be free of selective outcome reporting
Quote: "The Kuopio University Hospital’s ethical committee approved the study protocol (N0. 64/00)."
Judgement Comment: Study protocol not available, but the study appears free of selective outcome reporting
Judgement Comment: No reference to study protocol, but the study appears to be free of selective outcome reporting
reference: Jensen et al., 2015
Judgement Comment: No reference to study protocol, but appears to be free of selective outcome reporting
Judgement Comment: There is no reference to study protocol, but the study appears to be from selective outcome reporting
Judgement Comment: No reference to study protocol, but the study appears to be free of selective outcome reporting
Bias due to problems not covered elsewhere in the table
Judgement Comment: There were significant differences between the groups on severeal baseline characterisstics, including challanging behavior, reaction (RBMBC), but otherwise no other apparent sources of bias
Judgement Comment: The study appears to be free of other sources of bias.
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: The study appears to be free of other sources of bias
reference: Jensen et al., 2015
Judgement Comment: The study appears to be from other sources of bias
Judgement Comment: The study appears to be free from other sources of bias
Judgement Comment: The study appears to be free of other sources of bias