Alzheimer's DiseaseD_CareGiverNCT02685787
Early Counseling and Support for Alzheimer's Disease Caregivers
A study testing Psychosocial Intervention and Educational Intervention on AD in people with Alzheimer's Disease, run by Azienda Sanitaria Locale N.1 dell'Umbria at 1 site in Italy.
Trial summary
This randomized trial evaluates the efficacy of counselling for reducing anxiety and depression in caregivers of patients with dementia. Half of the participants will receive six hours providing counselling and psycho-social support to caregivers along with a specific telephone support service - Ad Hoc Telephone… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Psychosocial Intervention and Educational Intervention on AD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2012to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caregiver actively caring the patient for at least 4 hours a day over the last 6 months.
- Their patients must have scored lower than 24 on the Mini-Mental State Examination score, at screening.
- Their patients must have at least one limitation according to the Activities of Daily Living (ADL) test, or two limitations based on the Instrumental Activities of Daily Living (IADL) test.
Who cannot join
- Self-reported current psychiatric history, not related to patient's disease
- caregiver of non-AD dementias
- their patients could not undergo clinical and neuropsychological evaluation
- caregiver with insufficient Italian language knowledge
- can not be contacted by telephone regularly (eg. Do not have telephone/mobile, severe auditory deficits).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
USL Umbria 1
Perugia, 06127
Serena Amici, MD, PhD, serena.amici@uslumbria1.it
Alberto Trequattrini, MD
About this study
Official title: Can Early Counseling and Support for Alzheimer's Disease Caregivers Improve Burden? A Multi-centre Active Randomized Clinical Trial in Local Health Services
This randomized trial evaluates the efficacy of counselling for reducing anxiety and depression in caregivers of patients with dementia. Half of the participants will receive six hours providing counselling and psycho-social support to caregivers along with a specific telephone support service - Ad Hoc Telephone Counselling whereas the remaining participants will receive six hours providing general information about Alzheimer Disease.
Read the detailed description
This study will be a multicentre Umbrian PROBE design (treatment regimens are blinded to both caregivers and evaluators) with investigating the effectiveness comparing two active treatment "counseling and support" versus "educational group focusing on AD" in 230 primary caregivers of AD patients.
If all inclusion criteria are met, the caregiver will be asked to sign a written informed consent form. Failure to do so, will result in exclusion from the study. 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-hour sessions.
Care providers and Study settings
Caregiver will be recruited in secondary outpatient clinic located in Umbrian health maintenance organizations (HMO). Outpatient clinic in Umbria are disseminated in the territory and each small city has its own clinic (Città di Castello, Foligno, Gualdo Tadino, Gubbio, Perugia, Marsciano, Passignano, San Giustino, Spoleto, Terni, Todi, Umbertide with population ranging from 11,000 to 166,000 inhabitants, of them around 70% living in the country/small village). Care providers were neurologist and geriatrician with twelve to 30 year experience in dementia practice, working in high volume outpatient clinic.
INTERVENTION
Treatment arm
Psychosocial Intervention
Every caregiver will be assigned to a permanent counselor. The caregiver in the intervention arm will meet the counselors six times in person. 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 held within 4 months of the initial assessment. Interventions will be tailored for the caregivers based upon:
- depression and anxiety;
- burden;
- self care and health-related behavior;
- social support; and
- behavioral symptoms.
The design and management of the structured intervention will follow a published counseling caregiver manual, based on the experiences matured at New York University. Every session will be documented.
Moreover, the counselor will make three ad hoc telephone calls to the caregiver each month following the six in-person sessions counseling, in order to monitor the well-being of the caregiver. Telephone communications will be documented; other types of communication will not be considered valid (e.g. telephone text messages or social network messages).
Finally, the counselor will be available to the caregiver via a telephone service.
All counselors will meet monthly to update the the adherence to the protocol to resolve any problems.
Educational Intervention on AD
The caregiver enrolled in this arm:
- will not receive counseling or support;
- will participate to group sessions;
- the six hours sessions will divulge information on AD using a slide-show.
Each session will focus on the following topic:
- diagnosis and treatment,
- cognitive deficit management,
- behavioral disturbance management,
- daily living management,
- non-pharmacological treatment,
- legal issues and available health and social services.
Additionally, contrary to other arm, caregivers will not receive any telephone calls after the end of the educational sessions.
Whenever a caregiver in this arm requires additional support, he/she will be referred to volunteers of the local Alzheimer's Association.
Follow-up evaluation
Caregivers will be evaluated at 6, 12, and 24 months after baseline evaluation; outcome measures will repeated at every evaluation. Patients will be evaluated every twelve months after baseline, as standard care requires. The implementation of the intervention program will be closely monitored, including activities as well as outcomes. 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 a move to another city or state, hospitalization, a nursing home admission, or death will be recorded.
The study will be under constant monitoring of an External Committee.
- Conditions
- Alzheimer's Disease
- Being tested
- Psychosocial Intervention, Educational Intervention on AD
- Keywords
- Care-giver burden, Dementia, Alzheimer's disease, Care-giver depression, Care-giver anxiety
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial InterventionBehavioural
The caregiver in the intervention arm will meet the counselors 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. Interventions will be tailored for the caregivers based upon: 1) depression and anxiety; 2) burden; 3) self care and health-related behavior; 4) social support; and 5) behavioral symptoms. The design and management of the structured intervention will follow a published counseling caregiver manual, based on the experiences matured at New York University. Every session will be documented.
Educational Intervention on ADBehavioural
The caregiver enrolled in this arm:1) will not receive counseling or support; 2) will participate to group sessions; 3) the six hours sessions will divulge information on AD using a slide-show. Each session will focus on the following topic: (a) diagnosis and treatment b) cognitive deficit management, c) behavioral disturbance management, d) daily living management, e) non-pharmacological treatment, f) legal issues and available health and social services.
Additionally, contrary to other arm, caregivers will not receive any telephone calls after the end of the educational sessions.
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial Intervention | Experimental | Every caregiver in this arm will be assigned to a permanent counselor. Receives: Behavioral: Psychosocial Intervention |
| Educational Intervention on AD | Active comparator | The caregiver enrolled in this arm will not be assigned to a counselor but will participate to group sessions on AD education. Receives: Behavioral: Educational Intervention on AD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care-giver burden measured with Zarit Burden Inventory (ZBI)
Change from baseline of care-giver burden at 6 months
Measured: ZBI evaluated at 6 months
Care-giver burden measured with ZBI
Change from baseline of care-giver burden at 12 months
Measured: ZBI evaluated at 12 months
Care-giver burden measured with ZBI
Change from baseline of care-giver burden at 24 months
Measured: ZBI evaluated at 24 months
Secondary outcomes (5)
Caregiver depression measured using the Hospital Anxiety and Depression Scale (HADS)
Measured: At baseline, and after 6 months, 12 and 24 months from baseline
Behavioural and psychological symptoms of dementia (BPSD) using the Neuropsychiatric Inventory (NPI)
Measured: At baseline, and after 6 months, 12 and 24 months from baseline
BPSD using the Revised Memory and Behaviour Checklist (RMBC)
Measured: At baseline, and after 6 months, 12 and 24 months from baseline
Patient quality-of-life measure with Logdson's Quality of Life AD
Measured: At baseline, and after 6 months, 12 and 24 months from baseline
Care-giver quality-of-life measure with Euro-Quality of Life
Measured: At baseline, and after 6 months, 12 and 24 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startApr 2012
- Primary completionJan 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale N.1 dell'Umbria
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera di Perugia, S. Maria Hospital, Terni, Azienda Unità Sanitaria Locale Umbria n. 2
- Responsible party
- Principal investigator, Serena Amici, Azienda Sanitaria Locale N.1 dell'Umbria
- Investigators
- Alessandro Montedori, MD, Study chair, Regional Health Authority of Umbria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685787
- Sponsor's protocol ID
- GR-2009-1607340
- Acronym
- D_CareGiver
- Status last verified
- Feb 2016
- First submitted
- 6 Feb 2016
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Adelman RD, Tmanova LL, Delgado D, Dion S, Lachs MS. Caregiver burden: a clinical review. JAMA. 2014 Mar 12;311(10):1052-60. doi: 10.1001/jama.2014.304.
PubMed 24618967Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.
PubMed 3337862Andren S, Elmstahl S. Effective psychosocial intervention for family caregivers lengthens time elapsed before nursing home placement of individuals with dementia: a five-year follow-up study. Int Psychogeriatr. 2008 Dec;20(6):1177-92. doi: 10.1017/S1041610208007503. Epub 2008 Jul 8.
PubMed 18606052Binetti G, Mega MS, Magni E, Padovani A, Rozzini L, Bianchetti A, Trabucchi M, Cummings JL. Behavioral disorders in Alzheimer disease: a transcultural perspective. Arch Neurol. 1998 Apr;55(4):539-44. doi: 10.1001/archneur.55.4.539.
PubMed 9561983Brodaty H, Green A, Koschera A. Meta-analysis of psychosocial interventions for caregivers of people with dementia. J Am Geriatr Soc. 2003 May;51(5):657-64. doi: 10.1034/j.1600-0579.2003.00210.x.
PubMed 12752841Chattat R, Cortesi V, Izzicupo F, Del Re ML, Sgarbi C, Fabbo A, Bergonzini E. The Italian version of the Zarit Burden interview: a validation study. Int Psychogeriatr. 2011 Jun;23(5):797-805. doi: 10.1017/S1041610210002218. Epub 2010 Dec 16.
PubMed 21205379Cuijpers P. Depressive disorders in caregivers of dementia patients: a systematic review. Aging Ment Health. 2005 Jul;9(4):325-30. doi: 10.1080/13607860500090078.
PubMed 16019288Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.
PubMed 7991117Joling KJ, van Marwijk HW, Smit F, van der Horst HE, Scheltens P, van de Ven PM, Mittelman MS, van Hout HP. Does a family meetings intervention prevent depression and anxiety in family caregivers of dementia patients? A randomized trial. PLoS One. 2012;7(1):e30936. doi: 10.1371/journal.pone.0030936. Epub 2012 Jan 27.
PubMed 22303473Mittelman MS, Brodaty H, Wallen AS, Burns A. A three-country randomized controlled trial of a psychosocial intervention for caregivers combined with pharmacological treatment for patients with Alzheimer disease: effects on caregiver depression. Am J Geriatr Psychiatry. 2008 Nov;16(11):893-904. doi: 10.1097/JGP.0b013e3181898095.
PubMed 18978250Mittelman MS, Haley WE, Clay OJ, Roth DL. Improving caregiver well-being delays nursing home placement of patients with Alzheimer disease. Neurology. 2006 Nov 14;67(9):1592-9. doi: 10.1212/01.wnl.0000242727.81172.91.
PubMed 17101889Schulz R, Beach SR. Caregiving as a risk factor for mortality: the Caregiver Health Effects Study. JAMA. 1999 Dec 15;282(23):2215-9. doi: 10.1001/jama.282.23.2215.
PubMed 10605972Schulz R, Martire LM. Family caregiving of persons with dementia: prevalence, health effects, and support strategies. Am J Geriatr Psychiatry. 2004 May-Jun;12(3):240-9.
PubMed 15126224Wimo A, Jonsson L, Zbrozek A. The Resource Utilization in Dementia (RUD) instrument is valid for assessing informal care time in community-living patients with dementia. J Nutr Health Aging. 2010 Oct;14(8):685-90. doi: 10.1007/s12603-010-0316-2.
PubMed 20922346
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Early Counseling and Support for Alzheimer's Disease Caregivers Improve Burden? A Multi-centre Active Randomized Clinical Trial in Local Health Services
- ClinicalTrials.gov ID
- NCT02685787
- Acronym / sponsor ID
- D_CareGiver / GR-2009-1607340
- Conditions
- Alzheimer's Disease
- Keywords
- Care-giver burden, Dementia, Alzheimer's disease, Care-giver depression, Care-giver anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale N.1 dell'UmbriaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera di Perugia, S. Maria Hospital, Terni, Azienda Unità Sanitaria Locale Umbria n. 2
- Study start
- Apr 2012
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized trial evaluates the efficacy of counselling for reducing anxiety and depression in caregivers of patients with dementia. Half of the participants will receive six hours providing counselling and psycho-social support to caregivers along with a specific telephone support service - Ad Hoc Telephone Counselling whereas the remaining participants will receive six hours providing general information about Alzheimer Disease.
Detailed description
This study will be a multicentre Umbrian PROBE design (treatment regimens are blinded to both caregivers and evaluators) with investigating the effectiveness comparing two active treatment "counseling and support" versus "educational group focusing on AD" in 230 primary caregivers of AD patients.
If all inclusion criteria are met, the caregiver will be asked to sign a written informed consent form. Failure to do so, will result in exclusion from the study. 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-hour sessions.
Care providers and Study settings
Caregiver will be recruited in secondary outpatient clinic located in Umbrian health maintenance organizations (HMO). Outpatient clinic in Umbria are disseminated in the territory and each small city has its own clinic (Città di Castello, Foligno, Gualdo Tadino, Gubbio, Perugia, Marsciano, Passignano, San Giustino, Spoleto, Terni, Todi, Umbertide with population ranging from 11,000 to 166,000 inhabitants, of them around 70% living in the country/small village). Care providers were neurologist and geriatrician with twelve to 30 year experience in dementia practice, working in high volume outpatient clinic.
INTERVENTION
Treatment arm
Psychosocial Intervention
Every caregiver will be assigned to a permanent counselor. The caregiver in the intervention arm will meet the counselors six times in person. 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 held within 4 months of the initial assessment. Interventions will be tailored for the caregivers based upon:
- depression and anxiety;
- burden;
- self care and health-related behavior;
- social support; and
- behavioral symptoms.
The design and management of the structured intervention will follow a published counseling caregiver manual, based on the experiences matured at New York University. Every session will be documented.
Moreover, the counselor will make three ad hoc telephone calls to the caregiver each month following the six in-person sessions counseling, in order to monitor the well-being of the caregiver. Telephone communications will be documented; other types of communication will not be considered valid (e.g. telephone text messages or social network messages).
Finally, the counselor will be available to the caregiver via a telephone service.
All counselors will meet monthly to update the the adherence to the protocol to resolve any problems.
Educational Intervention on AD
The caregiver enrolled in this arm:
- will not receive counseling or support;
- will participate to group sessions;
- the six hours sessions will divulge information on AD using a slide-show.
Each session will focus on the following topic:
- diagnosis and treatment,
- cognitive deficit management,
- behavioral disturbance management,
- daily living management,
- non-pharmacological treatment,
- legal issues and available health and social services.
Additionally, contrary to other arm, caregivers will not receive any telephone calls after the end of the educational sessions.
Whenever a caregiver in this arm requires additional support, he/she will be referred to volunteers of the local Alzheimer's Association.
Follow-up evaluation
Caregivers will be evaluated at 6, 12, and 24 months after baseline evaluation; outcome measures will repeated at every evaluation. Patients will be evaluated every twelve months after baseline, as standard care requires. The implementation of the intervention program will be closely monitored, including activities as well as outcomes. 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 a move to another city or state, hospitalization, a nursing home admission, or death will be recorded.
The study will be under constant monitoring of an External Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychosocial Intervention | Experimental | Behavioral: Psychosocial InterventionEvery caregiver in this arm will be assigned to a permanent counselor. |
| Educational Intervention on AD | Active comparator | Behavioral: Educational Intervention on ADThe caregiver enrolled in this arm will not be assigned to a counselor but will participate to group sessions on AD education. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Caregiver actively caring the patient for at least 4 hours a day over the last 6 months.
- Their patients must have scored lower than 24 on the Mini-Mental State Examination score, at screening.
- Their patients must have at least one limitation according to the Activities of Daily Living (ADL) test, or two limitations based on the Instrumental Activities of Daily Living (IADL) test.
Key exclusion criteria (5 listed)
- Self-reported current psychiatric history, not related to patient's disease
- caregiver of non-AD dementias
- their patients could not undergo clinical and neuropsychological evaluation
- caregiver with insufficient Italian language knowledge
- can not be contacted by telephone regularly (eg. Do not have telephone/mobile, severe auditory deficits).
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 |
|---|---|---|
| Psychosocial InterventionThe caregiver in the intervention arm will meet the counselors 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. Interventions will be tailored for the caregivers based upon: 1) depression and anxiety; 2) burden; 3) self care and health-related behavior; 4) social support; and 5) behavioral symptoms. The design and management of the structured intervention will follow a published counseling caregiver manual, based on the experiences matured at New York University. Every session will be documented. | Behavioural | Psychosocial Intervention |
| Educational Intervention on ADThe caregiver enrolled in this arm:1) will not receive counseling or support; 2) will participate to group sessions; 3) the six hours sessions will divulge information on AD using a slide-show. Each session will focus on the following topic: (a) diagnosis and treatment b) cognitive deficit management, c) behavioral disturbance management, d) daily living management, e) non-pharmacological treatment, f) legal issues and available health and social services. Additionally, contrary to other arm, caregivers will not receive any telephone calls after the end of the educational sessions. | Behavioural | Educational Intervention on AD |
Primary outcome
Care-giver burden measured with Zarit Burden Inventory (ZBI)
Time frame: ZBI evaluated at 6 months
Change from baseline of care-giver burden at 6 months
Care-giver burden measured with ZBI
Time frame: ZBI evaluated at 12 months
Change from baseline of care-giver burden at 12 months
Care-giver burden measured with ZBI
Time frame: ZBI evaluated at 24 months
Change from baseline of care-giver burden at 24 months
5 secondary outcomes
Caregiver depression measured using the Hospital Anxiety and Depression Scale (HADS)
Time frame: At baseline, and after 6 months, 12 and 24 months from baseline
Behavioural and psychological symptoms of dementia (BPSD) using the Neuropsychiatric Inventory (NPI)
Time frame: At baseline, and after 6 months, 12 and 24 months from baseline
BPSD using the Revised Memory and Behaviour Checklist (RMBC)
Time frame: At baseline, and after 6 months, 12 and 24 months from baseline
Patient quality-of-life measure with Logdson's Quality of Life AD
Time frame: At baseline, and after 6 months, 12 and 24 months from baseline
Care-giver quality-of-life measure with Euro-Quality of Life
Time frame: At baseline, and after 6 months, 12 and 24 months from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Results publication: PubMed 24618967Adelman RD, Tmanova LL, Delgado D, Dion S, Lachs MS. Caregiver burden: a clinical review. JAMA. 2014 Mar 12;311(10):1052-60. doi: 10.1001/jama.2014.304.
- Results publication: PubMed 3337862Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.
- Results publication: PubMed 18606052Andren S, Elmstahl S. Effective psychosocial intervention for family caregivers lengthens time elapsed before nursing home placement of individuals with dementia: a five-year follow-up study. Int Psychogeriatr. 2008 Dec;20(6):1177-92. doi: 10.1017/S1041610208007503. Epub 2008 Jul 8.
- Results publication: PubMed 9561983Binetti G, Mega MS, Magni E, Padovani A, Rozzini L, Bianchetti A, Trabucchi M, Cummings JL. Behavioral disorders in Alzheimer disease: a transcultural perspective. Arch Neurol. 1998 Apr;55(4):539-44. doi: 10.1001/archneur.55.4.539.
- Results publication: PubMed 12752841Brodaty H, Green A, Koschera A. Meta-analysis of psychosocial interventions for caregivers of people with dementia. J Am Geriatr Soc. 2003 May;51(5):657-64. doi: 10.1034/j.1600-0579.2003.00210.x.
- Results publication: PubMed 21205379Chattat R, Cortesi V, Izzicupo F, Del Re ML, Sgarbi C, Fabbo A, Bergonzini E. The Italian version of the Zarit Burden interview: a validation study. Int Psychogeriatr. 2011 Jun;23(5):797-805. doi: 10.1017/S1041610210002218. Epub 2010 Dec 16.
- Results publication: PubMed 16019288Cuijpers P. Depressive disorders in caregivers of dementia patients: a systematic review. Aging Ment Health. 2005 Jul;9(4):325-30. doi: 10.1080/13607860500090078.
- Results publication: PubMed 7991117Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.
- Results publication: PubMed 22303473Joling KJ, van Marwijk HW, Smit F, van der Horst HE, Scheltens P, van de Ven PM, Mittelman MS, van Hout HP. Does a family meetings intervention prevent depression and anxiety in family caregivers of dementia patients? A randomized trial. PLoS One. 2012;7(1):e30936. doi: 10.1371/journal.pone.0030936. Epub 2012 Jan 27.
- Results publication: PubMed 18978250Mittelman MS, Brodaty H, Wallen AS, Burns A. A three-country randomized controlled trial of a psychosocial intervention for caregivers combined with pharmacological treatment for patients with Alzheimer disease: effects on caregiver depression. Am J Geriatr Psychiatry. 2008 Nov;16(11):893-904. doi: 10.1097/JGP.0b013e3181898095.
- Results publication: PubMed 17101889Mittelman MS, Haley WE, Clay OJ, Roth DL. Improving caregiver well-being delays nursing home placement of patients with Alzheimer disease. Neurology. 2006 Nov 14;67(9):1592-9. doi: 10.1212/01.wnl.0000242727.81172.91.
- Results publication: PubMed 10605972Schulz R, Beach SR. Caregiving as a risk factor for mortality: the Caregiver Health Effects Study. JAMA. 1999 Dec 15;282(23):2215-9. doi: 10.1001/jama.282.23.2215.
- Individual participant dataSharing planned: Undecided
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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.
Alessandro Montedori, MD study chair
Regional Health Authority of Umbria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial Intervention and Educational Intervention on AD in people with Alzheimer's Disease, run by Azienda Sanitaria Locale N.1 dell'Umbria at 1 site in Italy.
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 5 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: status not confirmed, as of the sponsor's last update on 19 Feb 2016. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serena Amici, MD, PhD (+393394384847, serena.amici@uslumbria1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Care-giver burden measured with Zarit Burden Inventory (ZBI) (time frame: ZBI evaluated at 6 months). The study lists 3 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 NCT02685787, which also lists 14 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 19 Feb 2016.