Telephone-based aftercare groups for family carers of people with dementia - results of a mixed-methods process evaluation of a randomized controlled trial.

BACKGROUND: Caring for a relative with dementia can be demanding and time-consuming. It is not uncommon for them to be overburdened and overworked, which can lead to symptoms of depression or anxiety disorders in 2/3 of cases. One possibility for treating family carers who have these issues is special medical rehabilitation (rehab). However, studies have shown that while such rehab is effective, it is not sustainable. To increase the sustainability of rehab for this target group, structured telephone-based aftercare groups were implemented in the present study. A process evaluation was conducted focusing on the acceptability of the aftercare programme and its perceived benefits by the participating family carers and group moderators. METHODS: The process evaluation was embedded in a longitudinal randomized controlled trial and followed a mixed methods approach. Quantitative process data were collected using protocols and structured brief evaluations regarding the telephone-based aftercare groups. To assess the acceptability of the aftercare groups as well as their subjective evaluation by the participants, qualitative process data were collected through two longitudinal telephone-based interviews with a subsample of family carers as well as a focus group interview with the group moderators. RESULTS: Telephone-based aftercare groups provide acceptable and supportive experiences, and they are shown to be practicable. The content structure and the procedure of the group sessions could be easily implemented in everyday life after inpatient rehab. The topics addressed with each patient were met with a consistently positive response. Learning from the other group members and sharing a bond based on the experience of caring for a relative with dementia were evaluated as positive outcomes in the group. The universality of suffering as a central effective factor of group psychotherapy also played a decisive role in this telephone-based support group format for a shared bonding and strengthening experience in the groups and thus for their effectiveness. CONCLUSION: Telephone-based aftercare groups for family carers of people with dementia are a useful and acceptable tool in the context of rehab aftercare. This location-independent aftercare programme could be adapted for other indications, focuses or topics in everyday care. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00013736, 14/05/2018.

Telephone-based aftercare groups for family carers of people with dementia - results of the effect evaluation of a randomised controlled trial.

BACKGROUND: The care of people with dementia is associated with enormous stress and, in a quarter of cases, leads to depression and anxiety disorders in the caring relatives. A specially designed inpatient psychosomatic rehabilitation (rehab) programme for family carers of people with dementia has proven to be effective but not sustainable. Therefore, the present study aims to increase the sustainability of the inpatient rehab programme by using thematically structured telephone aftercare group sessions. METHODS: The effectiveness of telephone aftercare groups was investigated in a randomized, controlled, prospective, mixed methods, longitudinal study. The aftercare intervention included social participation in monthly telephone group sessions for 6 months. The primary outcome was increased social participation of family carers, which, like the secondary outcomes (such as quality of life and subjective health), was assessed in written surveys at three or four measurement points. RESULTS: Complete data from 69 participants from the intervention group and from 72 participants from the control group could be evaluated. A small-sized reduction in restrictions on social participation was observed in the intervention group, whereas the reduction in the control group was negligible. The repeated-measures analysis of variance (ANOVA) showed sustained effects on the secondary outcomes, such as depression, perceived social support, and the mental health domain of quality of life of family carers, in favour of the intervention group. The results also showed that telephone-based aftercare groups had a rather minor influence on the use of support services. Except for those from family, friends and neighbours, existing support offers were hardly used. CONCLUSION: Telephone aftercare group sessions for carers of people with dementia were not able to increase social participation at the expected magnitude. Nevertheless, the clear effects on selected secondary health-related outcomes and the assessment of the telephone-based group sessions by the participants show that the caring relatives were able to benefit greatly from this aftercare measure. Family carers should be informed more extensively about the corresponding resources and encouraged to use them. Overall, this new aftercare concept can be recommended for implementation, and its use also seems to be target-oriented for other indications. CLINICAL TRIAL REGISTRATION: German Clinical Trials Register: DRKS00013736 , 14/05/2018.

TALKING TIME: A pilot randomized controlled trial investigating social support for informal caregivers via the telephone.

BACKGROUND: Caring for people with dementia at home requires considerable time, organization and commitment. Therefore, informal caregivers of people with dementia are often overburdened. This study examined the effects of the telephone-based Talking Time intervention, which is an approach used to strengthen the psychological health-related quality of life (HRQoL) and social support of informal caregivers of people with dementia living at home. METHODS: This study was a Medical Research Council framework phase two randomized controlled trial. The intervention consisted of a preliminary talk, information booklet, six structured telephone-based support group meetings and a structured written self-evaluation of each support group meeting. The control participants performed their usual individual self-organized care. After completing the data collection, the control group received the Talking Time intervention for fidelity reasons. The primary outcome was the self-rated psychological HRQoL of the informal caregivers, which was measured with the mental component summary of the General Health Survey Questionnaire Short Form 12 (SF-12). RESULTS: Thirty-eight informal caregivers and their relatives were included and allocated to the intervention or control groups (n = 19 each). After 3 months, the Talking Time intervention group demonstrated an increase in the self-rated psychological HRQoL scores, whereas the scores decreased in the control group. However, the standardized effect size of 1.65 (95% Confidence Interval, - 0.44 - 3.75) was not significant. Additionally, the secondary outcomes demonstrated no significant results. The differences between the groups in most outcomes were in the expected direction. No adverse effects were identified due to the intervention. CONCLUSIONS: The Talking Time intervention is feasible and shows nonsignificant promising results with regard to the self-rated psychological HRQoL. After further adjustment, the intervention needs to be evaluated in a full trial. TRIAL REGISTRATION: Clinical Trials: NCT02806583 , June 9, 2016 (retrospectively registered).

Telephone-based aftercare groups for family carers of people with dementia: study protocol of the Talking Time - REHAB project.

BACKGROUND: More than one million people in Germany live with dementia. Most of these people are cared for at home in the family setting. Supporting and caring for people with dementia is time-consuming, and family carers often have high stress levels and are at an increased risk of becoming physically and mentally ill. Medical rehabilitation (rehab) helps to relieve family carers and provide them with strategies to cope with stress. The aim of this study is to improve the sustainability of a multimodal rehab program for family carers of people with dementia. RESEARCH QUESTION: can the effects of this rehab be maintained through telephone-based aftercare groups following the rehab program? METHODS: A prospective randomized controlled longitudinal trial is performed. The intervention group (IG) participates in telephone-based aftercare groups; the control group (CG) receives treatment as usual. For evaluation, a mixed-methods approach is used. The effects of the intervention are quantitatively evaluated by written questionnaires at four measuring points (pre- and post-rehab, as well as 6 and 12 months after the end of rehab). PRIMARY OUTCOME: participation (IMET). SECONDARY OUTCOMES: Depressive Mood State CES-D, General Complaints SCL-90-R, Subjective Quality of Life WHOQUOL-BREF, Social Support F-SozU, performance in different areas of life, single scales, and support offers (single items). The intervention process is evaluated through qualitative interviews and focus groups with regard to the acceptance of and satisfaction with the aftercare offered; in addition, a health economic evaluation is performed using the EQ-5D questionnaire. Rehabilitants are included in the study (N = 103 each in the IG and CG) who, accompanied by their family members with dementia, participate in the rehab measure in Ratzeburg. The IG participates monthly in 6 telephone aftercare groups over a period of 6 months. Typical stress situations are discussed and worked on. DISCUSSION: Upon successful evaluation, the offer to participate in telephone-based aftercare groups can be firmly established in the participating rehab clinic. Through minor adjustments, the offer would also be suitable for carers of physically ill people and for non-nursing-specific rehabilitation indications. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00013736 , May 14, 2018.

Item distribution, internal consistency, and structural validity of the German version of the DEMQOL and DEMQOL-proxy.

BACKGROUND: Accurate assessment of health-related quality of life as an endpoint in intervention studies is a major challenge in dementia research. The DEMQOL (29 items) and the proxy version (32 items), which is partly based on the DEMQOL, are internationally used instruments. To date, there is no information on the structural validity, item distribution, or internal consistency for the German language version of these questionnaires. METHODS: This psychometric study is based on a secondary data analysis of a sample of 201 outpatients with a mild form of Alzheimer's disease (AD) and their informal caregivers. The informal caregivers who were interviewed were involved in the care of the person with AD several times per week. The analysis for the evaluation of the structural validity was performed using Mokken scale analysis. The internal consistency was calculated using the ρ of the Molenaar Sijtsma statistic and Cronbach's α. RESULTS: For both versions, four subscales were identified: [A] "positive emotions", [B] "negative emotions", [C] "physical and cognitive functioning", and [D] "daily activities and social relationships". For both instruments, the internal consistency of all subscales was considered "good" (ρ = 0.71-0.88, α = 0.72-0.87). CONCLUSIONS: The results are a first indication of good construct validity of the instruments used for the German setting. We recommend further investigations of the test-retest reliability and the inter-rater reliability of the proxy instrument.

Individualized support for informal caregivers of people with dementia - effectiveness of the German adaptation of REACH II.

BACKGROUND: Individualized, outreach and structured multicomponent interventions are a promising intervention approach to relieve the burden of informal caregivers of people with dementia. In this study, we adapted and evaluated a multicomponent intervention (Resources for Enhancing Alzheimer's Caregiver Health II, REACH II), which was developed in the USA, to the German health-care system. Therefore the project is called the German adaptation of REACH II (in German: Deutsche Adaptation der REACH II, DE-REACH). METHODS: The effectiveness of DE-REACH was examined in a randomized, controlled trial on 92 informal caregivers of people with dementia. The intervention comprised 12 individual two-weekly sessions (9 at home with the informal caregiver and 3 via telephone) and combined five modules. The reduction of the burden of the informal caregivers was chosen as the primary outcome. RESULTS: The results showed a great stabilizing effect of the intervention on caregiver burden (effect size d = 0.91), that is, comparing pre- and post-measurements the burden decreased very slightly in the intervention group whereas it increased very strongly in the control group. After a three-month follow-up period this effect decreased from a great to a moderate effect. There were also improvements as a result of the intervention in somatization, health-related psychological quality of life and the reaction of the informal caregivers in response to challenging behaviors of the relative with dementia. Moreover, the frequency of challenging behaviors of the affected person itself was reduced in favor of the intervention. CONCLUSION: The findings of this study provide further evidence for the impact of multicomponent support interventions for informal caregivers of people with dementia. CLINICAL TRIAL REGISTRATION: NCT01690117 . Registered September 17, 2012.

Feasibility and effectiveness of a telephone-based social support intervention for informal caregivers of people with dementia: Study protocol of the TALKING TIME project.

BACKGROUND: Caring for people with dementia at home requires a significant amount of time, organization, and commitment. Therefore, informal caregivers, mainly relatives, of people with dementia often feel a high burden. Although on-site support groups are known to have positive effects on the subjective well-being (SWB) and perceived social support of informal caregivers, there are cases in which relatives have either no time or no opportunity to leave the person alone or in which there are no support groups nearby. The TALKING TIME project aims to close this supply gap by providing structured telephone-based support groups in Germany for the first time. International studies have shown benefits for informal caregivers. METHODS: The TALKING TIME study is a randomized controlled trial. The effects of the 3-month TALKING TIME intervention will be compared with those of a control group without intervention at two time points (baseline = T0, after 3 months = T1). The control group will receive the TALKING TIME intervention after T1. With a planned sample size of 88 participants, the study is powered to detect an estimated effect size of 0.70 for psychological quality of life, considering an α of 0.05 (two-sided), a power of 80%. Caregivers are informal caregivers who are eligible if they are 18 years of age or older and have cared for a person with diagnosed dementia for at least four hours, four days per week, in the past six months. The exclusion criteria are psychiatric disorders of the informal caregiver. The primary outcome is the mental component summary of the SF-12 rated by informal caregivers. The secondary outcomes for informal caregivers are the physical component summary of the SF-12, the Perceived Social Support Caregiver Scale (SSCS) score, and the Caregiver Reaction Scale (CRS) score. The secondary outcome for care recipients is the Neuropsychiatric Inventory (NPI-Q). For the process evaluation, different quantitative and qualitative data sources will be collected to address reach, fidelity, dosage and context. DISCUSSION: The results will provide further information on the effectiveness and optimization of telephone-based support groups for informal caregivers of people with dementia, which can help guide the further development of effective telephone-based social support group interventions. TRIAL REGISTRATION: Clinical Trials: NCT02806583 , June 9, 2016.

German adaptation of the Resources for Enhancing Alzheimer's Caregiver Health II: study protocol of a single-centred, randomised controlled trial.

BACKGROUND: Caring for a family member with dementia is extremely stressful, and contributes to psychiatric and physical illness among caregivers. Therefore, a comprehensive programme called Resources for Enhancing Alzheimer's Caregiver Health II (REACH II) was developed in the United States to enhance the health of Alzheimer's caregivers. REACH II causes a clear reduction of the stress and burdens faced by informal caregivers at home. The aim of this protocol is to adapt, apply, and evaluate this proven intervention programme in a German-speaking area for the first time. This newly adapted intervention is called Deutsche Adaption der Resources for Enhancing Alzheimer's Caregiver Health (DeREACH). METHODS: A total of 138 informal caregivers at home are recruited in a single-centred, randomised controlled trial. The intervention (DeREACH) consists of nine home visits and three telephone contacts over six months, all of which focus on safety, psychological well-being and self-care, social support, problem behaviour and preventive health-related behaviours. A complex intervention assessment on effectiveness will be adopted when the primary outcome - namely, the reduction of caregiver burden - and other secondary outcomes, including changes with regard to anxiety and depression, somatisation, health-related quality of life, and perceived social support, are measured at baseline, as well as immediately and three months after the intervention. The change from baseline to post-intervention assessment with regard to the primary outcome will be compared between treatment and control group using t-tests for independent samples. DISCUSSION: It is anticipated that this study will show that DeREACH effectively reduces caregiver burden and therefore works under the conditions of a local German health-care system. If successful, this programme will provide an effective intervention programme in the German-speaking area to identify and develop the personal capabilities of informal caregivers to cope with the burdens of caring for people with dementia.

Theoretical approaches to process evaluations of complex interventions in health care: a systematic scoping review protocol.

BACKGROUND: Complex interventions in health care are characterized by multiple interacting components as well as by numerous nonlinear interactions with the social systems within which they are being implemented. The process of developing, evaluating and implementing complex interventions is therefore challenging. Established guidance such as the MRC (Medical Research Council) framework for developing and evaluating complex interventions refers to process evaluations as an integral part of the development of complex evidence-based interventions. Even though the need for process evaluations is recognized, the realization of such approaches is challenging because methodological instruction is sparse, and the phenomenon of interest is complex. A number of theoretical approaches indicating how to conduct process evaluations of complex interventions in health care exist, but a systematic and comprehensive overview of these is missing. Thus, the objective of the systematic scoping review described herein is to provide an overview and analysis of theoretical approaches suitable for the planning and conducting of process evaluations. METHODS: The design and conduct of this review will follow the procedures of a systematic scoping review. The search strategy will be developed following the BeHEMoTh (Behaviour of interest; Health context; Exclusions; Models or Theories) template which has been conceptualized for structured reviews of theory. The systematic search of the MEDLINE (via PubMed), CINAHL (via EBSCO) and PsycInfo (via EBSCO) electronic databases will be complemented by "hand searching" techniques. Study selection, data extraction, and data analysis will be performed by tandems of two researchers independently of each other. Divergent decisions and judgements between the two researchers will be discussed by the whole review team. DISCUSSION: The findings from this scoping review will provide an overview and comparison of theoretical approaches suitable for process evaluations of complex interventions in health care. The review results will support researchers in choosing the theoretical approach that best fits the respective focus of their process evaluation study. SYSTEMATIC REVIEW REGISTRATION: This study has been registered with PROSPERO (International Prospective Register of Systematic Reviews) under registration number CRD42020211732 .

Anosognosia in Alzheimer's disease: the role of impairment levels in assessment of insight across domains.

Impaired insight for deficits (anosognosia) is common in Alzheimer's disease (AD). However, it has not yet been determined clearly (a) whether different methods for assessing insight are comparable, and (b) whether anosognosia affects different domains to different degrees (domain-specificity). Impaired insight was investigated in 32 patients with AD, who were each accompanied by a caregiver. Anosognosia was assessed by a global clinical rating, questionnaire discrepancies (patient vs. caregiver) covering different domains, and performance discrepancies (self-assessment vs. performance) based on four neuropsychological tests which were compared with those of a healthy control sample. The results of clinical rating and questionnaire discrepancies were closely correlated, but performance discrepancies showed no association with the other methods. Anosognosia was present in the majority of the sample, and occurred across domains. The domains corresponding to core deficits in AD (recent memory, activities of daily living) appeared especially prone to anosognosia. However, results do not suggest that anosognosia itself is domain-specific. Rather, it appears that insight may be invariant, while differences in patient-caregiver discrepancies arise largely from different degrees of deficit across domains.

Application of Marte Meo® counselling with people with behavioural variant frontotemporal dementia and their primary carers (AMEO-FTD) - a non-randomized mixed-method feasibility study.

BACKGROUND: One of the core symptoms of behavioural variant frontotemporal dementia (bvFTD) is the early loss of social cognitive abilities, which has a deteriorating impact on everyday interaction and the quality of dyadic relationships. Marte Meo® (MM) counselling is a video-based intervention that aims to maintain or improve the quality of dyadic relationships. This non-randomized mixed-method study aimed to evaluate the feasibility of the intervention in practice with primary carers of persons with bvFTD as well as the feasibility of a future confirmatory trial. METHODS: A pilot effect study with a quasi-experimental, one-group, pre-post design and double pre-measurement was conducted. Data were collected at three time points (t0, t1 after 2 weeks, and t2 after 6 weeks) using videography and several measurement instruments. Between t1 and t2, each primary carer received five MM counselling sessions. The outcomes included positive and negative affect, behavioural and psychological symptoms in dementia (BPSD), the interpersonal abilities of the person with dementia, the sensitivity and distress of the primary carers due to BPSD, the manageability of BPSD, the personal goal attainment by means of MM counselling, and the quality of the dyadic relationships. The pilot process evaluation focused on the primary carers' and the interventionist's perceived benefits and perceptions of the intervention process using questionnaires and interviews. RESULTS: Five dyads were enrolled. Regarding the feasibility of the intervention, MM counselling seems to be appropriate and useful for the target group. Although the recruitment of persons with reliable bvFTD diagnoses was very time consuming and complex, the intervention was well accepted by the dyads, and regarding goal attainment, all carers benefited as much or even more than they expected. The study also showed that the benefits of MM counselling depend on whether the primary carer has accepted his/her relative's dementia. Regarding the feasibility of a future confirmatory trial, certain outcomes, particularly positive affect, distress due to BPSD, and the quality of the dyadic relationship, seem to be appropriate for describing possible effects. CONCLUSION: Overall, the intervention seems feasible for this target group. A future confirmatory trial should be planned as a multicentre pilot trial with an extension option. TRIAL REGISTRATION: DRKS00014377. Registered retrospectively on April 11, 2018.