Responder Analysis of a Multicomponent Non-Pharmacological Intervention (MAKS) for People With Cognitive Impairment in the German Day-Care Study (DeTaMAKS).

Background: Multicomponent non-pharmacological therapies have been shown to be effective at reducing cognitive symptoms and slowing deterioration in abilities to perform activities of daily living (ADL) in individuals with cognitive impairment. However, little is known about response rates and predictors of response. Methods: We used data from the German day-care study (DeTaMAKS; De = dementia, Ta = Tagespflege/day-care, M = motor stimulation, A = activities of daily living stimulation, K = k/cognitive stimulation, S = social stimulation; n = 362), which was based on a cluster-randomized trial of the non-pharmacological, multicomponent, anti-dementia MAKS therapy for people with cognitive impairment in day-care centers. We investigated response (defined as improvement or no deterioration) for three different response criteria: cognition via Mini-Mental State Examination (MMSE) score, ADL via Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment (ETAM) score, and behavioral and psychological symptoms of dementia (BPSD) via Neuropsychiatric Inventory Questionnaire (NPI-Q) score. In addition, we calculated the number needed to treat (NTT) and response rates according to net gain analyses. Results: For all three criteria, the response rates were higher in the intervention group than in the control group (chi2 test: p = 0.058 to p = 0.003). Compared with non-responders, responders according to cognition had higher ETAM scores (= better ADL abilities) at baseline; responders according to ADL had lower ETAM scores (= poorer ADL abilities) at baseline; and responders according to BPSD had higher NPI-Q scores (= more BPSD) at baseline. Classification rates based on these predictors ranged from 60.6 to 68.3%. Discussion: The response rates to the non-pharmacological MAKS therapy were greater than those reported for anti-dementia drugs. There were only a few differences between responders and non-responders. Because of the low classification rates, these variables had only a small impact on response predictions. Therefore, there are no empirically substantiated selection criteria for the application of MAKS therapy in facilities. Clinical Trial Registration: www.ClinicalTrials.gov, identifier ISRCTN16412551.

Suicide Risk Factors in Patients Recently Discharged From a Psychiatric Hospital: A Case-Control Study.

OBJECTIVE: The first weeks after discharge from a psychiatric hospital constitute a period of considerably increased risk for suicide. Most studies on risk factors have investigated a relatively long time frame after discharge or have identified unmodifiable factors. This case-control study focused on factors describing the interaction between patient and hospital and studied variables during the entire course of the hospital stay. METHODS: Suicide cases were identified by linking the Tyrol Suicide Register (all suicides occurring in the Austrian state of Tyrol) with the registers of the 3 psychiatric hospitals in the state. Postdischarge suicide cases were defined as suicides occurring within 12 weeks after discharge. Control subjects were patients who had also been inpatients in the respective psychiatric unit but had not committed suicide. Matching variables included sex, age, hospital, diagnosis, and date of discharge. The study period comprised 7 years (February 1, 2004-January 31, 2011). RESULTS: A total of 89 suicide cases and 144 controls were included. Factors differentiating cases from controls included a history of suicidal behavior or threats (odds ratio [OR] = 4.65; P < .001), depressive symptoms (OR = 3.63; P = .004) and disordered thought content (OR = 2.68; P = .001) at admission, admission mode (patient self-referral less often [OR = 0.28; P = .009]), a change from one ward to another (OR = 1.87; P = .035), discharge initiated by the patient (OR = 10.34; P = .013), depressive symptoms at this point in time (OR = 4.42; P < .001), discharge mode (less often into institutional care [OR = 0.17; P = .002]), and linkage with postdischarge care (fixed appointment with a general practitioner less often [OR = 0.53; P = .024]). CONCLUSIONS: The results of this study point to suicide preventive measures that may be implemented during and after hospitalization, including clear information transfer in case of unavoidable ward change and optimization of follow-up care organization.

Can brief telephone interventions reduce caregiver burden and depression in caregivers of people with cognitive impairment? - long-term results of the German day-care study (RCT).

BACKGROUND: Day-care and telephone counseling have been discussed as effective support measures for caregivers of people with cognitive impairment. METHODS: In a two-arm cluster-randomized trial involving multicomponent therapy for cognitively impaired persons in day-care centers and telephone counseling for their caregivers versus treatment as usual (TAU), we investigated long-term effects on caregivers' burden and depressiveness. Person-caregiver dyads involving home-dwelling persons with MCI, mild dementia, or moderate dementia were eligible. Day-care centers were randomized into an intervention group (IG) or a control group (CG). Outcome assessors were blinded. Out of 359 caregivers who had completed a 6-month intervention phase (nIG = 205, nCG = 154), a total of 304 of them were available at the 12-month follow-up (nIG = 173, nCG = 131). Instruments for assessing were the Burden Scale for Family Caregivers - short version (BSFC-s) (caregiver burden) and the Well-Being Index Score (WHO-5) (depressiveness). Mixed ANOVAs were used for the main analyses; descriptive statistics and subgroup analyses were additionally performed; secondary analyses involved multiple linear regressions for the main outcomes that were significant in the unadjusted main analysis. RESULTS: At follow-up, crude mean differences showed a nonsignificant advantage for the IG in caregiver burden [IG: -.20 (SD = 5.39) vs. CG: .76 (SD = 5.49), p = .126, d = .177] and depressiveness (reverse scored) [IG: -.05 (SD = 5.17) vs. CG: -.98 (SD = 5.65), p = .136, d = .173]. For caregiver burden, a mixed ANOVA resulted in significant main effects of group (F (1, 302) = 4.40; p = .037) and time (F (1.88, 568.96) = 3.56; p = .032) but not a significant interaction. The largest effects were found for the "mild dementia" subgroup (d = .443 for caregiver burden and d = .520 for depressiveness). DISCUSSION: Positive long-term effects of a combined intervention involving telephone counseling for caregivers and multicomponent activation for patients were observed especially for mild dementia. However, the treatment effects washed out after the intervention ended. TRIAL REGISTRATION: ISRCTN16412551 (date: 30 July 2014, retrospectively).

Brief telephone counselling is effective for caregivers who do not experience any major life events - caregiver-related outcomes of the German day-care study.

BACKGROUND: To date, there has been a dearth of scientifically tested, established intervention concepts focussed on supporting informal caregivers and embedded in routine health care structures. The aim of this study was to assess effects of a brief telephone intervention for caregivers of persons with cognitive impairment (PCIs) on caregivers' depressiveness and subjective burden. METHODS: A two-arm cluster-randomised controlled intervention study was carried out at 32 German day-care centres. During the six-month intervention period, informal caregivers in the intervention group (n = 205) received counselling in three phone calls focussed on stress reduction, development of self-management strategies, and how to deal with challenging behaviours. Both the control group (n = 154) and the intervention group were free to take part in any support programmes offered by the German Health Care System (TAU). Caregivers' subjective burden and depressiveness were measured with the Burden Scale for Family Caregivers - short version (BSFC-s) and the WHO-5 Well-Being Index (WHO-5). Outcomes were assessed by means of computer-assisted telephone interviews (CATIs) at baseline and at the end of the six-month intervention phase. Multiple regression analyses were used to show the influence of group allocation. RESULTS: After the intervention phase, group allocation was not found to significantly predict caregivers' subjective burden or depressiveness. The baseline scores (p < 0.001) were the only significant predictors of change in both outcomes. However, sensitivity analyses for caregivers who did not experience any events that they felt were major (in a negative or positive sense) during the six months (n = 271) showed that group allocation (p < 0.05) was a significant predictor of positive change in both outcomes (BSFC-s: Δ-1.3, [- 2.4, - 0.3], Cohen's d = 0.27; WHO-5: Δ1.5, [0.4, 2.7], Cohen's d = 0.26). Effect sizes were highest in the subgroup of caregivers of people with mild dementia (BSFC-s: Cohen's d = 0.43; WHO-5: Cohen's d = 0.42). CONCLUSIONS: A "low-dose" psychoeducative telephone intervention designed to empower caregivers is effective, especially in an early stage, if the overlap between the effect of the intervention and the effect of events that are experienced as major events in the caregiver's life is considered. TRIAL REGISTRATION: Identifier: ISRCTN16412551 (Registration date: 30 July 2014, registered retrospectively).

Non-Pharmacological Treatment in People With Cognitive Impairment.

BACKGROUND: A number of non-pharmacological methods are available to help elderly people with cognitive impairment. Unstructured and non-evidencebased interventions are commonly used. The multicomponent therapy MAKS (a German acronym for Motor, Activities of daily living, Cognitive, Social) has already been evaluated in nursing homes; in this study, we investigated its use in day care centers (DCCs). METHODS: A cluster-randomized, controlled, single-blinded trial involving a 6-month intervention phase was performed. 362 cognitively impaired persons in 32 DCCs took part in the trial. Multiple regression analyses were used to determine whether MAKS therapy led to any statistically significant and clinically relevant improvement over time (compared to membership in the control group) in these persons' cognitive abilities and activities of daily living (ADL) abilities, as assessed, respectively, with the Mini-Mental State Examination (MMSE) and the Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment (ETAM). A primary per-protocol analysis was supplemented by an intention-to-treat analysis. Two secondary outcomes (social behavior and neuropsychiatric symptoms) were analyzed exploratively as well. Study registration: ISRCTN16412551. RESULTS: In the primary per-protocol analysis at 6 months, the intervention group had significantly better MMSE and ETAM scores than the control group (Cohen's d, 0.26 and 0.21, respectively; p = 0.012 for both). The same was found in the ITT analysis at 6 months (Cohen's d = 0.21, p = 0.033; and Cohen's d = 0.20, p = 0.019, respectively). Neuropsychiatric symptoms, one of the secondary outcomes, also evolved more favorably in the intervention group (Cohen's d = 0.23, p = 0.055). CONCLUSION: MAKS therapy is effective for persons with cognitive impairment ranging from mild cognitive impairment (MCI) to moderate dementia who live at home and regularly visit a day care center. The fact that 32 day care facilities from all over Germany participated in this study gives its findings high external validity.

The German day-care study: multicomponent non-drug therapy for people with cognitive impairment in day-care centres supplemented with caregiver counselling (DeTaMAKS) - study protocol of a cluster-randomised controlled trial.

BACKGROUND: It is the wish of both people with cognitive impairment and their informal caregivers for the impaired person to live at home for as long as possible. This is also in line with economic arguments about health. The existing structure of day-care services for the elderly can be used to achieve this. Due to the current lack of empirical evidence in this field, most day-care centres do not offer a scientifically evaluated, structured intervention, but instead offer a mixture of individual activities whose efficacy has not yet been established. Informal caregivers of people with dementia use day-care centres primarily to relieve themselves of their care tasks and as a support service. METHODS/DESIGN: The present study therefore investigates the effectiveness of a combination of a multicomponent activation therapy for people with mild cognitive impairment (MCI) or mild to moderate dementia at day-care centres and a brief telephone intervention for their informal caregivers. The study is conducted as a cluster-randomised intervention trial at 34 day-care centres in Germany with a 6-month treatment phase. The centres in the waitlist control group provide "care as usual". A power analysis indicated that 346 people should initially be included in the study. The primary endpoints of the study include the ability to perform activities of daily living (ADL) and cognitive capacities on the side of the day-care centre users and the subjectively perceived burden and well-being of the informal caregivers. The total duration of the study is 3 years, during which data are collected both by the psychometric testing of the people with cognitive impairment and by telephone interviews with informal caregivers. DISCUSSION: The project has three distinctive quality features. First, it is embedded in real care situations since the day-care services have already been established for this target group. Second, due to the large number of cases and the fact that the participating day-care centres are spread across the entire country, the results can be expected to be generalisable. Third, the interventions can be assumed to be implementable as they required only a one-day training event for the staff already working at the centres. TRIAL REGISTRATION: ISRCTN16412551 (Registration date: 30 July 2014, registered retrospectively).

A comparison of suicides in psychiatric in-patients, after discharge and in not recently hospitalized individuals.

OBJECTIVE: Time of in-patient treatment and the first weeks after hospital discharge have repeatedly been described as periods of increased suicide risk. This study compared demographic, clinical and suicide related factors between in-patient, post-discharge and not recently hospitalized suicides. METHODS: Suicide data from the Tyrol Suicide Register were linked with registers of three psychiatric hospitals in the state of Tyrol, Austria. Suicide cases then were categorized as in-patient suicides, post-discharge suicides (suicide within 12weeks after discharge) or never/not within 12weeks before death hospitalized suicides. Data were collected between 2004 and 2011. RESULTS: Of the total of 711 cases, 30 were in-patient, 89 post-discharge and 592 not recently hospitalized suicides. The three groups differed with regard to male-to-female ratio (lower in both hospitalized groups), marital status, suicide method used (jumping in in-patients, hanging in not recently hospitalized suicides), history of attempted suicide and suicide threats (highest in in-patients) and whether suicides had been in psychiatric or general practitioner treatment shortly before death. In most variables with significant differences there was a gradual increase/decrease with post-discharge suicides taking the middle place between the two other groups. CONCLUSIONS: The three suicide populations differed in a number of variables. Varying factors appear to influence suicide risk and choice of method differently in in-patient, post-discharge and not hospitalized suicides.