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 Table of Contents  
Year : 2016  |  Volume : 1  |  Issue : 3  |  Page : 99-106

Can early counselling and support for Alzheimer's disease caregivers reduce burden? Study protocol for a multicenter randomized controlled trial

1 Azienda Sanitaria Locale N.1 dell'Umbria, Perugia, Italy
2 Department of Medicine, University of Padua, Padua, Italy
3 National Centre for Epidemiology, Surveillance, and Health Promotion, National Institute of Health, Rome, Italy
4 Health Planning Service, Regional Health Authority of Umbria, Perugia, Italy
5 Department of Psychology, University of Bologna, Bologna, Italy

Date of Web Publication13-Oct-2016

Correspondence Address:
Iosief Abraha
Health Planning Service, Regional Health Authority of Umbria, Perugia
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Source of Support: This study was supported by a grant from Italian Ministry of Health (GR-2009-1607340)-Call for grant applications RF 2009 (Bando RicercaFinalizzata 2009-Ministero della Salute)., Conflict of Interest: None

DOI: 10.4103/2468-5658.191352

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Background: The activity of "caregiving" for people affected with Alzheimer's disease (AD) is associated with an augmentation in health problems (anxiety, depression, stress, increased mortality), as well as in social and financial problems. Different methods of counselling, to reduce caregiver anxiety and depression, have been shown to be effective.
Methods/Design: This study will be a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled superiority trial with two parallel groups. Two hundred and sixty-four caregivers of AD patients will be randomly allocated to the modified Mittelmann psychosocial intervention or an educational intervention. The treatment will consist of 6 hours of counselling and psychosocial support to caregivers, administered by psychologists, along with a specific telephone support service, whereas the active control treatment will be 6 hours of general information about AD. The primary endpoint is change in caregiver burden measured with the Zarit Burden Interview. Secondary endpoints comprise caregiver depression, anxiety and quality of life. All endpoints will be measured at baseline, 6, 12 and 24 months post treatment.
Discussion: The results of this trial will be helpful to supply the efficacy of early counselling and psychosocial support for AD caregivers and offer in-depth useful information for stakholders and policy makers to implement strategies for caregivers.
Trial registration: Clinical Trials.gov identifier: NCT02685787; registered on 6 February 2016.
Ethics: This trial has been approved by Umbria Ethical Review Committee, Italy and will be performed in accordance with the norms on Good Clinical Practice and the Helsinki Declaration.
Informed consent: Written informed consent will be obtained from the caregivers.

Keywords: clinical trial; Alzheimer′s disease; early counselling; caregiver burden; randomized controlled trial

How to cite this article:
Amici S, Iannizzi P, Di Pucchio A, Abraha I, Montedori A, Chattat R, Vanacore N. Can early counselling and support for Alzheimer's disease caregivers reduce burden? Study protocol for a multicenter randomized controlled trial. Clin Trials Degener Dis 2016;1:99-106

How to cite this URL:
Amici S, Iannizzi P, Di Pucchio A, Abraha I, Montedori A, Chattat R, Vanacore N. Can early counselling and support for Alzheimer's disease caregivers reduce burden? Study protocol for a multicenter randomized controlled trial. Clin Trials Degener Dis [serial online] 2016 [cited 2023 Nov 28];1:99-106. Available from: https://www.clinicaltdd.com/text.asp?2016/1/3/99/191352

  Introduction Top

The European population is considered to be the oldest in the world. By 2050, half of this population will be more than 50 years old, with a relative increase in the proportion of older people (more than 80 years old) (Ferri et al., 2005; Tsolova and Mortensen, 2006). Simultaneously, the percentage of the 15-64-year-old people will decrease, leading to a doubling of the elderly dependency ratio (the number of dependent people per independent people). In particular, the number of people suffering from dementia will rise two-fold in Western Europe and three times in Eastern Europe by 2030 (Europe A, 2006). The increased number of people affected by Alzheimer's disease (AD) and other dementias will amplify the need for caregiving and long-term care services.

In Italy and Europe, the majority of care is provided by unpaid family members, neighbours and friends - especially women (Europe A, 2006). The term "caregiver" refers to people involved in the provision of assistance to care recipients every day, regardless of professional or educational qualifications. On average, almost 68 percent of caregivers in EU countries are women, and about 60 percent of them are aged 30 to 59 years (Grammenos, 2005). Caregiving is generally unplanned, and most informal caregivers gradually adopt their roles, because of the insidious nature of dementia (Mittelman et al., 2003). Caregivers are not only the major providers of long-term care, but also are care managers, companions, surrogates, and decision-makers. This highly demanding occupation leads caregivers to experience health, social and financial problems (Cooke et al., 2001; Schulz and Martire, 2004; Cuijpers, 2005).

Caregivers suffer not only from depression, anxiety and burden (Cuijpers, 2005), but are also at higher risk for mortality (Schulz and Beach, 1999). In addition, since many people providing care are middle-aged, difficulties arise in combining informal caregiving with employment, and one out of four caregivers are required to leave work to care for their loved ones. Often, they become increasingly isolated from their social network of family and friends as the disease progresses. Lastly, a substantial financial commitment is required to care for a person with dementia (Censis, 1999, 2007).

Dementia caregivers usually spend more than 72 hours per week, in informal care to assist the person with dementia (Censis, 2007). The availability of family caregivers who help to maintain a person with dementia at home provides undoubted benefit for the patient, reduces the need for paid professional support, and consequently saves the Italian health care system financial resources. On the other hand, many caregivers are forced to give uptheir jobs. It has been estimated that in Italy, the annual savings for the Italian government due to unpaid informal care is around 24,100 Euros for each care recipient (Wimo and Jönsson, 2010).

Several psychosocial support programs for dementia caregivers have been developed, such as support groups, respite care, stress-management, social skills training, psycho-educational groups, and case management (Brodaty et al., 2003; Smits et al., 2007; Spijker et al., 2008). On the whole, multicomponent interventions providing caregivers with diverse services and types of support, and individually tailored interventions, showed larger effects on caregivers' well-being than others. These interventions effectively reduced caregiver stress, burden and mood disorders (Brodaty et al., 2003; Smits et al., 2007; Spijker et al., 2008) and delayed patient institutionalization (Mittelman et al., 2006; Spijker et al., 2008; Burns et al., 2010). However, these findings are based on studies with small sample sizes and short durations of follow-up (Olazaran et al., 2010).

One of the largest studies on depression and anxiety in dementia caregivers used the New York University Caregiver Intervention (NYUCI), a nonpharmacological, multicomponent intervention for spousal caregivers aimed at maintaining well-being by increasing social support and decreasing family discord, thereby delaying or avoiding nursing home placement of the person with dementia. NYUCI includes meeting a counsellor, six times over 4 months. This counselling focuses on: (1) depression and anxiety; (2) burden; (3) self-care and health-related behaviour; (4) social support; and (5) behavioural symptoms. In the first and the last sessions only the primary caregiver participates, whereas the secondary caregivers participate in the other four sessions (Mittelman et al., 2003).

The intervention proposed by Mary Mittelman has been reported to be beneficial over a 9-year follow-up. Later, the method was partially applied to a Dutch study and the "Three Country Study" (the United States, the United Kingdom and Australia), though their results were not comparable (Mittelman et al., 2006, 2008; Joling et al., 2012). Specifically, the latter two studies produced results inferior to the Mittelman study regarding depression and anxiety, which might have been due to the shorter follow-ups used in these two studies (Mittelman et al., 2008; Joling et al., 2012), different patient populations as well (Mittelman et al., 2008; Joling et al., 2012). In all these studies, all caregivers in the "usual care" arm had access to healthcare and welfare services, but not active treatment, although the available services were used by only 45% of enrolled caregivers.


The primary objective of this study is to compare the effectiveness of "early counselling and support for AD caregivers" and "educational group focusing on AD" in caregivers referred to Local Health Service (LHS) outpatient clinics in Umbria, Italy.

We hypothesised that "early counselling and support for AD caregivers" would be more effective than "active educational support group focusing on AD".

  Methods/Design Top

Study design

This study will be a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled superiority trial with two parallel groups (treatment regimens are known by both caregivers and counselors, but evaluators are blinded) involving 264 primary caregivers of AD patients.

Caregivers will be recruited from memory outpatient clinics in Umbrian LHUs. Outpatient clinics in Umbria are located in the following cities: Città di Castello, Foligno, Gualdo Tadino, Gubbio, Perugia, Marsciano, Passignano, San Giustino, Spoleto, Terni, Todi and Umbertide with populations ranging from 11,000 to 166,000 inhabitants, of which approximately 70% live in the country or a small village. Clinicians will be neurologists and geriatricians with at least twelve years experience in dementia practice, working in high volume outpatient clinics. [Figure 1] describes the flow diagram of patient recruitment and allocation.
Figure 1: Flow chart of the study design

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The primary endpoint is change in caregiver psychological burden from baseline to 6, 12 and 24 months post treatment. The secondary endpoints include: (1) reduction of caregiver depression (measured using the Hospital Anxiety and Depression Scale-Depression subscale); (2) reduction of caregiver anxiety (measured using the Hospital Anxiety and Depression Scale-Anxiety subscale); (3) assessment of Behavioural and Psychological Symptoms of Dementia (BPSD) in patients, measured using the Revised Memory and Behavior Checklist (RMBPC) and the Neuropsychiatric Inventory (NPI); (4) assessment of caregiver quality of life measured using the European Quality of Life (EuroQoL); (5) assessment of level of patient quality of life measured using Logdson's AD Quality of Life scale; (6) direct and indirect costs for the health care system.


Participants will be recruited from four sites located in Umbria, Italy: (i) Umbria Local Health Unit (LHU) n°1-Coordinator; (ii) Umbria LHU n°2; (iii) University Hospital of Perugia; and (iv) University Hospital of Terni. Senior dementia specialists (neurologists and geriatricians) will recruit caregivers during routine follow-up outpatient visits.

Inclusion criteria

Caregivers are eligible to be included in this trial if they meet the following criteria:

(a) informal caregiver (18 years or older; spouse, child, relative or friend) actively caring for the patient at least 4 hours-a-day over the last 6 months before enrolment; (b) patients receiving care must have: (i) a score lower than 24 on the Mini-Mental State Examination (MMSE), at screening; (ii) at least one limitation in the Activities of Daily Living (ADL), or two limitations in the Instrumental Activities of Daily Living (IADL).

Exclusion criteria

Caregivers will be excluded if they:

(a) have a self-reported current psychiatric condition, not related to the patient's disease; (b) provide care to people with non-AD dementias; (c) provide care to patients who could not undergo clinical and neuropsychological evaluation; (d) have insufficient knowledge of Italian; or (e) unable to be contacted regularly by telephone (e.g., do not have a land/mobile phone or severe auditory deficits).

When all inclusion criteria are met, the caregiver will be asked to sign a written informed consent form. The treatment will not be disclosed to the caregivers, although the caregivers will be told that they will participate in a study with two different active treatments which will require a total of six 1-hour sessions.

Sample size

Sample size calculation was based on an expected incidence rate of 30% for anxiety, depression and caregiver burden derived from the published scientific literature (Sansoni et al., 2004; Ferrara et al., 2008).

Based on the hypothesized reduction to 15% in the treatment arm, we determined that a study with 115 caregivers per group is needed to provide a power of 80%, with the use of a chi-square test with significance level of 0.05. Anticipating a withdrawal rate of 15%, 132 caregivers per group will be randomized.

Baseline assessment

Demographic data on all caregivers andcare recipients will be obtained at baseline. The patients will undergo an MMSE, while the caregiver will be asked to answer questions regarding the Activities of Daily Living (ADLs) and IADLs together with the Clinical Dementia Rating Scale. If patients and caregivers fulfill the inclusion criteria, they will be asked to participate in a research project comparing two interventions focused on psycho-education of AD caregivers. They will also be asked to participate in six 1-hour sessions and to be available to receive follow-up phone calls. If the consent form is signed, caregivers will be randomized and the following questionnaires will be administered at baseline: Resource Utilization in Dementia, Zarit Burden Interview (ZBI), Hospital Anxiety and Depression Scale (HADS), European Quality of Life, Revised Memory and Behavior Problem Checklist (RMBPC).

The following information regarding AD patients, of the enrolledcaregivers, will be recorded: estimated age of onset of AD, age at first diagnosis, MMSE, Clinical Dementia Rating Scale and ADL and IADL scores. The results of other cognitive tests used in clinical practice, such as Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), Cornell Depression Dementia Scale (CDDS), Neuropsychiatric Inventory (NPI), Quality of Life in Alzheimer's Disease QOL-AD and Clinical Insight Rating Scale (CIRS), will also be recorded if available.

AD patients will not be asked to sign a consent form since the project focused on caregivers, however they will be asked to give consent to undergo neuropsychological tests administered as standard care. Patient data entered in the database for clinical purposes will be matched to the parameters acquired in the caregiver population. The following information is usually collected during clinical evaluation: age, sex and education level.


All psychologists involved for caregiver psychological assessment and counselling and educational session will receive 15 hours of group training on endpoints and NYU counselling and support methods. All psychologists will be asked to read the manual for the NYU method (Mittelman et al., 2003). Written procedures were developed as a guide for the assessment and the training program. The 6-hour slide show for the educational intervention was developed, then reviewed and discussed by the training group before being approved in its final version. Each month all psychologists will meet to review case report forms and receive single case supervision.


All eligible caregivers who sign the consent form will be randomly allocated to a psychological intervention or to an educational intervention after baseline assessment. Randomization will be conducted using a central computerised registration system, designed for this study by the National Institute of Health (Istituto Superiore di Sanità), Italy which will not be involved in caregiver recruitment. Allocation concealment will be ensured by the statistician preparing the randomization codes using sealed, opaque and serially numbered envelopes.


Clinicians will not be involved in outcome assessment. Additionally, the psychologist who will evaluate caregivers will not administer the intervention and will not be aware of treatment allocation. Only the counsellor will be aware of the treatment. We will try to partially blind the caregivers by not describing the type of intervention, but only stating that they will participate in a trial assessing two different active interventions and that they will be required to participate in six 1-hour sessions.


Psychosocial intervention

Every caregiver will be assigned to a permanent counsellor. The caregiver in the intervention arm will meet the counsellor face-to-face six times. The first and the last sessions will be attended by the caregiver only, whereas the remaining four sessions will be attended by the caregiver and other family members who are involved in the daily management of the patient. All meetings will be held within 4 months of the initial assessment. The interventions will be tailored based on the following caregiver characteristics: (1) depression and anxiety, (2) burden, (3) self-care and health-related behaviour, (4) social support, and (5) behavioural symptoms. The design and management of the structuredintervention will follow a published counselling caregiver manual developed at New York University (Mittelman et al., 2003). Every session will be documented. Moreover, the counsellor will make three ad hoc telephone calls to the caregiver each month, following the six face-to-face counselling sessions, in order to monitor the well-being of the caregiver. Telephone calls will be documented; other types of communication will not be considered valid (e.g., telephone text messages or social network messages). Finally, the counsellor will be available for the caregiver via a telephone service. All counsellors will meet monthly to update adherence to the protocol and to resolve any problems.

Educational intervention

The caregivers enrolled in this arm: (1) will not receive counselling or support; (2) will participate in group sessionsin which information on AD will be provided through a slide-show. Each session will focus on the following topics: (a) diagnosis and treatment; b) cognitive deficit management; c) behavioural disturbance management; d) daily living management; e) non-pharmacological treatment; f) legal issues and available health and social services.

Additionally, caregivers in this group will not receive any telephone calls after the educational sessions end.Whenever a caregiver in this arm requires additional support, he/she will be referred to volunteers of the local Alzheimer's Association.

Study endpoints

[Table 1] lists the relative measures of the primary and secondary endpoints.
Table 1: Study emdpoints and measurement time points

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Primary endpoint

The primary endpoint is caregiver burden, measured with the Zarit Burden Interview, at baseline, 6, 12, and 24 months. The Zarit Burden Interview is a self-report measure of caregiver distress containing 22 items. Each item provides an example of a stressful situation usually experienced by caregivers. Respondents are asked if they experience the same situation, from never (0), to nearly always (4) (total score: 0-88). High scores indicate high levels of stress experienced by the respondent (Zarit et al., 1980; Wimo et al., 2010; Chattat et al., 2011).

Secondary endpoints

The secondary endpoints will include caregiver-related endpoints and AD patient-related endpoints.

The caregiver-related endpoints are:

a) Caregiver depression measured with the HADS-Depression subscale. HADS is a self-assessment scale to evaluate emotional distress. It is composed of two subscales, with seven items to measure anxiety and seven items to measure depression (total score: 0-42). Normative data consider scores between 0 and 7 as normal, scores from 8 to 10 as borderline, and scores 11 and above as clinically relevant states of anxiety and/or depression (Zigmond and Snaith, 1983; Costantini et al., 1999); b) caregiver anxiety measured with the HADS-Anxiety subscale; c) caregiver quality of life measured with the EuroQoL. The EuroQoL is commonly used to measure health-related quality of life. It consists of a visual analogue scale (EQ-VAS) of perceived overall health status, with a scores ranging from 0 (the worst possible health status) to 100 (the best possible health status) (EuroQol Group, 1990; Rabin and de Charro, 2001).

The AD patient-related endpoints are:

a) BPSD in patients, measured with the RMBPC and the NPI. The RMBPC is a 24-item caregiver-reported measure of observable behavioural problems in the patients with dementia. It provides a total score, as well as scores for three subscales: memory-related problems, psychological distress and disruptive behaviours (total scores range from 0 to 96) (Teri et al., 1992). The NPI is the most widely used instrument in clinical trials to assess dementia-related behavioural symptoms including delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, aberrant motor activity, night-time behavioural disturbances, appetite and eating abnormalities (Cummings et al., 1994; Binetti et al., 1998). The caregiver reports the frequency of symptoms using a 4-point scale and on severity according to a 3-point scale (total scores range from 0 to 144). The NPI also includes a 5-point subscale to measure caregiver distress. b) Quality of life of patients measured with Logdson's AD Quality of Life scale,as evaluated by the caregiver. This measure consists of 13 items, rated on a four-point scale, ranging from 1 (poor) to 4 (excellent) (total scores range from 13 to 52) (Logsdon et al., 1999).

All the secondary endpoints will be measured at baseline, 6, 12 and 24 months.

Lastly, direct and indirect costs for the health care system will be assessed. Using the suggestions of the panel on cost-effectiveness in health and medicine recommendations (Weinstein et al., 1996), intervention and control costs will be calculated for the following: (1) the amount of time staff spent training on the intervention and control protocols; (2) the amount of time staff spent on preparation and wrap-up; (3) the amount of time staff spent to deliver the intervention and (Spijker et al., 2008) control group protocols; (4) the amount of time caregivers spent assisting patients with AD; (5) the amount of supervisor and staff supervision time; (6) the amount of time and distance spent traveling, as well as materials used. Personnel costs will be calculated using perhour salary cost derived from annual salary and benefits. Costs for materials will be determined using actual costs. Travel costs will permit mileage reimbursement rates of Euro0.30 per kilometre for the distance travelled plus personnel costs related to the travel time.


Caregivers will be evaluated at 6, 12 and 24 months following baseline evaluation. Outcome measures will be obtained at every evaluation. Patients will be assessed every twelve months following baseline evaluation, as standard care requires. The implementation of the intervention program will be closely monitored, including activities and endpoints. The activities and progress of each caregiver and family will be tracked. The participation and attrition rate will be calculated and reported. The causes of delays in scheduling, or attrition due to moving to another city or state, hospitalization, nursing home admission, or death will be recorded. The study will be under constant monitoring by an External Committee.

Data analysis

Descriptive analysis will be performed to compare baseline socio-demographic, endpoint variables of both the intervention and control groups. Statistics to evaluate change over time (mixed-effect regression models) will be used. Intention-to-treat analysis will be performed to evaluate recorded data. We will calculate the effect of the psychosocial intervention on the primary endpoint (using the Zarit Burden Interview) with the chi-square test and multivariate models (logistic regression analysis). We will calculate the effect of the psychosocial intervention on the secondary endpoints with the Student's t-test for independent samples and regression models. In addition, we will use multivariate analysis to control for confounding variables such as age, sex, caregiving relationship, shared household, functional impairment and disability. The main analyses will be conducted using the software package STATA 13 (Stata Corp., College Station, TX, USA).

  Discussion Top

To our knowledge this is the first Italian multicenter randomized trial that compare the efficacy of two active psychosocial interventions in reducing AD caregiver burden, stress and anxiety. To date only few studies compared two active psychosocial interventions (Zarit et al., 1987; Farran et al., 2007).

Advantages of the study are: (1) the comparison of two active treatments so every caregiver will receive an intervention independently from arm allocation, contrary to most studies that used waiting list as control arm; this direct comparison could lead to results that help health policy maker in designing services dedicated to caregiver; (2) 15-hour training of psychologists that delivered the two interventions before the intervention started, as well the monthly meeting dedicated to issues raised in the counselling sessions; the training and the supervision will ensure uniformity of managing caregiver issues; (3) the presence of only AD caregiver (and not caregiver of patients with other dementias) will help tailoring the intervention to this specific population.

Limitations of the study are: (1) the relatively short follow-up, (2) the inability to include caregiver that cannot reach the local health services to participate in the intervention.

If the effectiveness study will show the superiority of one intervention over the other, future studies could focus on implementing the intervention by analyzing barriers and facilitators to participation and adherence to this psycho-social intervention.[36]

  References Top

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Conflicts of interest
None declared.
Author contributions
SA, RC and NV conceived and designed the study; PA, SA, ADP were involved in the project management; SA, PI, IA, AM, RC, ADP and NV contributed in the drafting and revising the paper and have approved submission of the final version of the manuscript.
We gratefully thank the caregivers involved in the study for devolving their precious time to this study.
Plagiarism check
This paper was screened twice using CrossCheck to verify originality before publication.
Peer review
This paper was double-blinded and stringently reviewed by international expert reviewers.


  [Figure 1]

  [Table 1]

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