DementiaDelpHiNCT01401582
Intervention Study to Improve Life and Care for People With Dementia and Their Caregivers in Primary Care
A study testing Implementation of Dementia Care Manager in people with Dementia, run by German Center for Neurodegenerative Diseases (DZNE) at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 to 120 years
- Conditions the study is for
- Dementia
- What is being tested?
- Implementation of Dementia Care Manager
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 634 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 70+ years
- must be living at home
- screening positive (DEMTECT < 9), indicating dementia
Who cannot join
- medical conditions not allowing testing
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Community Medicine
Greifswald, Mecklenburg- Western Pommerania, 17489
About this study
Official title: Dementia: Life- and Personcentered Help in Germany
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Dementia
- Being tested
- Implementation of Dementia Care Manager
- Keywords
- health care, dementia care, caregiver support, epidemiological study
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of Dementia Care ManagerOther
Also called Dementia Care Manager, Care Management, counselling, supporting caregivers
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.
| Study group | Role | What they receive |
|---|---|---|
| care as usual | No intervention | care as usual, no intervention, just observation of natural change/ trajectories over time |
| Implementation of Dementia Care Manager | Experimental | Subjects in this arm will be provided with a specialised "Dementia Care Manager" to be included in a subsidiary support system Receives: Other: Implementation of Dementia Care Manager |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: one year after baseline assessment
Secondary outcomes (5)
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.
Measured: 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
Measured: 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)
Measured: 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).
Measured: 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
Measured: participants will be followed yearly until institutionalisation or death after an expected average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startJan 2012
- Primary completion31 Mar 2016
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 634 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)
- Sponsor type
- University, hospital or other
- Collaborators
- University Medicine Greifswald
- Responsible party
- Principal investigator, René Thyrian, German Center for Neurodegenerative Diseases (DZNE)
- Investigators
- Wolfgang Hoffmann, MD, MPH, Principal investigator, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401582
- Sponsor's protocol ID
- DZNE_DelpHi-MV_001
- Acronym
- DelpHi
- Status last verified
- Aug 2025
- First submitted
- 18 Jul 2011
- Last updated
- 20 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.
PubMed 12021425Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
PubMed 9153155Erzigkeit H, Lehfeld H, Pena-Casanova J, Bieber F, Yekrangi-Hartmann C, Rupp M, Rappard F, Arnold K, Hindmarch I. The Bayer-Activities of Daily Living Scale (B-ADL): results from a validation study in three European countries. Dement Geriatr Cogn Disord. 2001 Sep-Oct;12(5):348-58. doi: 10.1159/000051280.
PubMed 11455136Fiss T, Ritter CA, Alte D, van den Berg N, Hoffmann W. Detection of drug related problems in an interdisciplinary health care model for rural areas in Germany. Pharm World Sci. 2010 Oct;32(5):566-74. doi: 10.1007/s11096-010-9409-6. Epub 2010 Jul 1.
PubMed 20593238Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
PubMed 10568646Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.
PubMed 6622612Sandholzer H, Hellenbrand W, Renteln-Kruse W, Van Weel C, Walker P. [STEP--standardized assessment of elderly people in primary care]. Dtsch Med Wochenschr. 2004 Dec 10;129 Suppl 4:S183-226. doi: 10.1055/s-2004-836107. German.
PubMed 15592957Wimo A, Nordberg G, Jansson W, Grafstrom M. Assessment of informal services to demented people with the RUD instrument. Int J Geriatr Psychiatry. 2000 Oct;15(10):969-71. doi: 10.1002/1099-1166(200010)15:103.0.co;2-9. No abstract available.
PubMed 11044880Bullinger M, Kirchberger I. SF-36 Fragenbogen zum Gesundheitszustand. Göttingen 1998: Hogrefe-Verlag GmBH & Co.KG; 1998
Fydrich T, Sommer G, Brähler E. F-SozU. Fragebogen zur sozialen Unterstützung. Göttingen: Hogrefe; 2007.
Zank S, Schacke C, Leipold B. Berliner Inventar zur Angehörigenbelastung - Demenz (BIZA-D). Zeitschrift für Klinische Psychologie und Psychotherapie 2006; 35(4):296-305.
Monsch AU. [Neuropsychological examination in evaluating dementia]. Praxis (Bern 1994). 1997 Aug 27;86(35):1340-2. German.
PubMed 9381025Reiner K, Eichler T, Hertel J, Hoffmann W, Thyrian JR. The Clock Drawing Test: A Reasonable Instrument to Assess Probable Dementia in Primary Care? Curr Alzheimer Res. 2018;15(1):38-43. doi: 10.2174/1567205014666170908101822.
PubMed 28891446Eichler T, Thyrian JR, Hertel J, Richter S, Michalowsky B, Wucherer D, Dreier A, Kilimann I, Teipel S, Hoffmann W. Patient Variables Associated with the Assignment of a Formal Dementia Diagnosis to Positively Screened Primary Care Patients. Curr Alzheimer Res. 2018;15(1):44-50. doi: 10.2174/1567205014666170908095707.
PubMed 28891445Wucherer D, Thyrian JR, Eichler T, Hertel J, Kilimann I, Richter S, Michalowsky B, Zwingmann I, Dreier-Wolfgramm A, Ritter CA, Teipel S, Hoffmann W. Drug-related problems in community-dwelling primary care patients screened positive for dementia. Int Psychogeriatr. 2017 Nov;29(11):1857-1868. doi: 10.1017/S1041610217001442. Epub 2017 Aug 7.
PubMed 28780910
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dementia: Life- and Personcentered Help in Germany
- ClinicalTrials.gov ID
- NCT01401582
- Acronym / sponsor ID
- DelpHi / DZNE_DelpHi-MV_001
- Conditions
- Dementia
- Keywords
- health care, dementia care, caregiver support, epidemiological study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 634 participants (actual)
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)University, hospital or other
- Collaborators
- University Medicine Greifswald
- Study start
- Jan 2012 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 Jul 2011 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| care as usual | No intervention | –care as usual, no intervention, just observation of natural change/ trajectories over time |
| Implementation of Dementia Care Manager | Experimental | Other: Implementation of Dementia Care ManagerSubjects in this arm will be provided with a specialised "Dementia Care Manager" to be included in a subsidiary support system |
Who may qualify
- Ages
- 70 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 70+ years
- must be living at home
- screening positive (DEMTECT < 9), indicating dementia
Key exclusion criteria (1 listed)
- medical conditions not allowing testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of Dementia Care ManagerAlso: Dementia Care Manager, Care Management, counselling, supporting caregiversHome-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. | Other | Implementation of Dementia Care Manager |
Primary outcome
Change in Quality of Life
Time frame: one year after baseline assessment
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.
Change in Caregiver Burden
Time frame: one year after baseline assessment
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
Change in Behavioral and Psychological Symptoms of Dementia
Time frame: one year after baseline assessment
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).
Change in Medical Treatment With Antidementia Drugs
Time frame: one year after baseline assessment
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).
Reduction of Potential Inapropriate Medication (PIM)
Time frame: one year after baseline assessment
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.
5 secondary outcomes
Person With Dementia: Change in Activities of Daily Living
Time frame: one year after baseline assessment
Person With Dementia: Change in Social Support
Time frame: 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
Time frame: 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
Time frame: participants will be followed yearly until institutionalisation or death after an expected average of 5 years
Person With Dementia: Change in Medication
Time frame: participants will be followed yearly until institutionalisation or death after an expected average of 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12021425Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.
- Background: PubMed 9153155Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
- Background: PubMed 11455136Erzigkeit H, Lehfeld H, Pena-Casanova J, Bieber F, Yekrangi-Hartmann C, Rupp M, Rappard F, Arnold K, Hindmarch I. The Bayer-Activities of Daily Living Scale (B-ADL): results from a validation study in three European countries. Dement Geriatr Cogn Disord. 2001 Sep-Oct;12(5):348-58. doi: 10.1159/000051280.
- Background: PubMed 20593238Fiss T, Ritter CA, Alte D, van den Berg N, Hoffmann W. Detection of drug related problems in an interdisciplinary health care model for rural areas in Germany. Pharm World Sci. 2010 Oct;32(5):566-74. doi: 10.1007/s11096-010-9409-6. Epub 2010 Jul 1.
- Background: PubMed 10568646Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
- Background: PubMed 6622612Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.
- Background: PubMed 15592957Sandholzer H, Hellenbrand W, Renteln-Kruse W, Van Weel C, Walker P. [STEP--standardized assessment of elderly people in primary care]. Dtsch Med Wochenschr. 2004 Dec 10;129 Suppl 4:S183-226. doi: 10.1055/s-2004-836107. German.
- Background: PubMed 11044880Wimo A, Nordberg G, Jansson W, Grafstrom M. Assessment of informal services to demented people with the RUD instrument. Int J Geriatr Psychiatry. 2000 Oct;15(10):969-71. doi: 10.1002/1099-1166(200010)15:103.0.co;2-9. No abstract available.
- BackgroundBullinger M, Kirchberger I. SF-36 Fragenbogen zum Gesundheitszustand. Göttingen 1998: Hogrefe-Verlag GmBH & Co.KG; 1998
- BackgroundFydrich T, Sommer G, Brähler E. F-SozU. Fragebogen zur sozialen Unterstützung. Göttingen: Hogrefe; 2007.
- BackgroundZank S, Schacke C, Leipold B. Berliner Inventar zur Angehörigenbelastung - Demenz (BIZA-D). Zeitschrift für Klinische Psychologie und Psychotherapie 2006; 35(4):296-305.
- Background: PubMed 9381025Monsch AU. [Neuropsychological examination in evaluating dementia]. Praxis (Bern 1994). 1997 Aug 27;86(35):1340-2. German.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Hoffmann, MD, MPH principal investigator
University Medicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of Dementia Care Manager in people with Dementia, run by German Center for Neurodegenerative Diseases (DZNE) at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (time frame: one year after baseline assessment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01401582, which also lists 48 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.