Intervention Study to Improve Life and Care for People With Dementia and Their Caregivers in Primary Care

Study Overview
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Brief Summary
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Caring for people with dementia and treating them is a major challenge for the health care system in Germany. Among the challenges for population-based health care research are (a) identification and early recognition, (b) multimorbidity and (c) the integration of persons with dementia into the health care system. One setting which is identified to meet the challenges is the primary care setting and there especially the general physician. There have been a few interventional studies, which have been restricted to selective samples and have been conducted in inpatient settings. The purpose of this study is to test the efficacy of implementing a subsidiary support system for persons with dementia living at home. This subsidiary support system is initiated by a Dementia Care Manager (DCM), a nurse with dementia-specific advanced training. The main goals are to improve quality of life and health care of the person with dementia and reduce caregiver´s burden. The study is a general physician based cluster-randomised controlled intervention trial. A population based sample of general physicians will be asked to participate in a systematic screening trial to identify people with dementia in primary care in Mecklenburg Western Pommerania (MV), a federal state in Germany. Upon identification the people will be asked to participate in the DelpHi-MV study and after having given written informed consent will then be assigned to an intervention and a control group. Identification of people with dementia will be achieved by a short screening questionnaire in the physician's office. An extended in-depth data assessment will be conducted after inclusion into the study and then annually to measure the course of the people's health. Data assessment will be done at the people's homes. People assigned to the intervention group will receive an intervention provided by Dementia Care Manager. The Dementia Care Manager is a specialised nurse that is going into the person's home to manage the care of dementia as well as caring for the person's relative/ or carer.

Detailed Description
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The Dementia: life- and person-centered help in Mecklenburg-Western Pomerania (DelpHi) trial was a pragmatic, general practitioner (GP)-based, cluster-randomized intervention study with two arms, an intervention group and a care as usual (CAU) group. T The design, eligibility and inclusion criteria, intervention and baseline characteristics of the trial have been described in detail elsewhere. To reduce the risk of contamination across groups, GP practices were the unit of randomization and determined the patients´ group status. At the beginning of the study, a total of 854 GPs in 5 municipalities of Mecklenburg-Western Pomerania were invited to participate by mail. GPs expressing an interest in the study were visited by the investigators to convey additional detailed information about the study. Finally, 136 GPs (16%) gave written informed consent (IC) to participate and agreed to adhere to the DelpHi-study protocol. There were no restrictions regarding the GPs' treatment of patients. GPs systematically assessed the eligibility of patients for the trial during routine care (eligibility criteria for screening: age >70 years, living at home). Patients were screened using screening procedure. This individual interview-based instrument is widely used for dementia screening in GP practices in Germany. Patients who screened positive were informed about the study by their GP, invited to participate and asked to provide written IC. If the patients listed a caregiver, he or she was asked to participate as well. When patients were unable to provide written IC, their legal representative was asked to sign the consent form on their behalf. The study physicians received allowances for performing the screening (10€ per patient) and study enrollment (100€ per patient). Identical, standardized, computer-assisted face-to-face interviews with all participants were conducted at the participants' homes by specifically trained nurses over an average of three separate visits (1) immediately after study inclusion (baseline) and (2) 12 months later (follow-up). To minimize participant burden, the assessment sessions were restricted to one hour. Dementia Care Management is a complex intervention that aims to provide optimal care by integrating multi-professional and multimodal strategies for improving patient- and caregiver-related outcomes. DCM individualizes and optimizes dementia treatment and care within the framework of the established health care and social service system. It was developed according to current guidelines targeted at the individual participant level and delivered at participants´ homes by 6 nurses with dementia-specific training. Nurses were supported by a computer-based intervention-management system (IMS) to improve systematic identification of patients' and caregivers' unmet needs and the subsequent recommendation of interventions to address these needs. The training as well as software are described in more detail elsewhere. The primary outcomes pertain to the individual participants: (a) Quality of life, measured by the Quality of Life in Alzheimer's Disease instrument (QolAD); (b) Caregiver burden, measured by the Berlin Inventory of Caregivers' Burden with Dementia Patients (BIZA-D); (c) Behavioral and psychological symptoms, measured by the Neuropsychiatric Inventory (NPI); (d) Use of pharmacotherapy with antidementia drugs, which included the following substances recommended by relevant guidelines: donepezil, galantamine, rivastigmine, and memantine; and (e) Use of potentially inadequate medication (PIM), evaluated using the Priscus criteria.. Sample size: No previous data on the main outcome measures were available to use for sample size calculation. Therefore, sample size was estimated based on theoretical assumptions. In the design, the minimally important difference (MID) for determining the efficacy was considered to be of at least a small effect, defined by Cohen's d (d = 0.2 48). Comparing two groups at a significance level of α = 0.05, assuming a statistical power of 80% and an intra-class correlation with clustering by GP practice of zero a sample size of 310 persons per group would have been sufficient 48. Considering the longitudinal design, we accounted for a loss over time of 35% (death, withdrawal of IC) and determined that 477 persons per group with complete datasets would have been needed to be included in the study. We estimated that GPs would identify n=1,000 participants over the course of 2 years. Recruitment turned out to be slower than expected. Thus recruitment was prolonged from two to three years. The sample size achieved allows to detect a medium effect size (Cohen´s d=0.5) 48. Randomization/allocation We used simple 1:1 randomization without stratification or matching. This procedure was sufficient due to the high number of expected clusters in our study 49. GPs were not informed of their randomization status. However, due to the type of intervention, GPs became aware of their status throughout the course of the study. Participants were recruited and enrolled by participating GPs but allocated to the study group by study center. Since baseline assessment and delivery of intervention needed to be performed by the same nurses, a blinding was not possible.

Official Title
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Dementia: Life- and Personcentered Help in Germany

Conditions
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Dementia

Intervention / Treatment
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* Other: Implementation of Dementia Care Manager


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 70+ years must be living at home screening positive (DEMTECT < 9), indicating dementia Exclusion Criteria: medical conditions not allowing testing

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: care as usual<br>care as usual, no intervention, just observation of natural change/ trajectories over time | |
| Experimental: Implementation of Dementia Care Manager<br>Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system | Other: Implementation of Dementia Care Manager<br>* Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.<br>* Other names: supporting caregivers;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | The Quality of Life in Alzheimer's Disease (Qol-AD; Logsdon et al. 2002) was used. This measure designed specifically to obtain a rating of the patient's quality of life from both the patient and the caregiver. Each item is rated on a four point scale, with 1 being poor and 4 being excellent. Total scores, obtained by the sum of all 13 items, range from 13 to 52. | one year after baseline assessment | 
| Change in Caregiver Burden | Caregiver burden was assessed using the Berliner Inventar zur Angehörigenbelastung - Demenz (BIZA-D) (Zank et al., 2006). The BIZAD was developed to assess objective as well as subjective burden due to caring for a person wit dementia (PWD). It consists of 88 items covering 20 dimensions of caregiver burden. Objective burden is divided into six dimensions: 1) basic care tasks like support eating, hygiene etc (7 items), 2) extended care tasks like supporting grocery shopping, legal affairs etc. (3 items), 3) Motivation and Guidance (4 items), 4) emotional support (4 items), 5) supporting maintenance of social contacts (3 items) and 6) supervision (4 items). Each item has to be rated regarding the frequency of the support needed on a 5-Point scale (example: supervision; Does the patient need this kind of support: 1=always, 2= mostly, 3=partly, 4=hardly, 5= not at all). Then each item asks: Who is providing this support: all by someone else, mostly by someone else, evenly distributed | one year after baseline assessment | 
| Change in Behavioral and Psychological Symptoms of Dementia | Neuropsychiatric Inventory (NPI; Cummings 1997); The NPI represents an interview by proxy on twelve dimensions of neuropsychiatric behaviors, i.e. delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The presence (0= no, 1= yes) is asked. If present, the severity (rated 1 through 3; mild to severe) and frequency (1 to 4, rarely to very often) of each neuropsychiatric symptom are rated on. Thus the score for each dimension ranges from 0 = not present, 1= mildly and rarely to 12 = severe and often. A total NPI score is calculated as the sum of the frequency by severity scores ofeach domain range: 0 to 144, the higher the more neuropsychiatric symptomatic). | one year after baseline assessment | 
| Change in Medical Treatment With Antidementia Drugs | medication was systematically reviewed; A computer-based home medication review (HMR) encompasses all medications used by the study participants and includes questions about compliance, adverse effects and drug administration. The collection of primary data on medication in the context of the HMR includes both prescription drugs and over-the-counter drugs. The assignment was then integrated using a master file of the Pharmaceutical Index. The following antidementia drugs were considered: donepezil (N06AD02), rivastigmine (N06AD03), galantamine (N06AD04) and memantine (N06AX01). | one year after baseline assessment | 
| Reduction of Potential Inapropriate Medication (PIM) | Having to deal with multimorbidity and polypharmacy in a sample of chronically ill elderly, we also analyze potentially inappropriate medication (PIM), defined as a drug for which the risk of an adverse event outweighs the clinical benefit, particularly when there is evidence in favor of a safer or more effective alternative therapy for the same condition. The PIM were identified using the Priscus list, which contains 83 drugs from 18 different drug classes. | one year after baseline assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Person With Dementia: Change in Activities of Daily Living | The functional status was assessed using the Bayer Activities of Daily Living Scale (B-ADL). It coonsits of 25 Items indicating everyday problems/ challenges. Their occurence is rated on a scale of 1 never, to 10 always. All ratings are added and divided by the number of items. This yields a mean score of 1 to 10, where 1 indicates the lowest possible impairment and 10 indicates the highest possible impairment. | one year after baseline assessment | 
| Person With Dementia: Change in Social Support | The F-SozU (Fydrich et al. 2007) will be used to assess social support in several domains | participants will be followed yearly until institutionalisation or death after an expected average of 5 years | 
| Person With Dementia and Caregiver: Change in Health Status | Several instruments will be used to assess the health of the person with dementia: the GP records the Fragebogen zum SF12- health survey (SF-12, Bullinger et al. 1998) the standardized assessment of elderly in primary care (STEP; Sandholzer et al. 2004) the Brief Symptom Inventory (BSI; Derogatis et al. 1983) the Patient´s health questionnaire (PHQ-D; Löwe et al. 2002, Spitzer et al. 1999) | participants will be followed yearly until institutionalisation or death after an expected average of 5 years | 
| Person With Dementia: Change in Utilization of Health Care Resources | frequency of utilisation of general physicians and physicians of other specialties out-patient treatments in-patient treatments hospitalisations institutionalisation therapeutic appliances standardised assessment with the Resource Utilization in Dementia (RUD, Wimo et al. 1998). | participants will be followed yearly until institutionalisation or death after an expected average of 5 years | 
| Person With Dementia: Change in Medication | The DCM will conduct an IT-supported home medication review (Fiss et al., 2010) at the patients home with subsequent medication management by the local pharmacy regarding frequency of drug related problems, intake of PIM, clinically relevant drug-drug interaction, adherence, utilisation of adherence supporting activities (medication plan, drug dispenser, support by care service, reduction of the number of drugs taken | participants will be followed yearly until institutionalisation or death after an expected average of 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health care, dementia care, caregiver support, epidemiological study