Early Counseling and Support for Alzheimer's Disease Caregivers

NCT02685787 | Unknown DMC

• 1 other identifier: GR-2009-1607340
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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 Counselling whereas the remaining participants will receive six hours providing general information about Alzheimer Disease.

Conditions

Alzheimer's Disease

Keywords

Care-giver burden; Dementia; Alzheimer's disease; Care-giver depression; Care-giver anxiety

Outcome Measures

Primary Outcomes (3)

• Care-giver burden measured with Zarit Burden Inventory (ZBI)

  Change from baseline of care-giver burden at 6 months

  ZBI evaluated at 6 months

• Care-giver burden measured with ZBI

  Change from baseline of care-giver burden at 12 months

  ZBI evaluated at 12 months

• Care-giver burden measured with ZBI

  Change from baseline of care-giver burden at 24 months

  ZBI evaluated at 24 months

Secondary Outcomes (5)

• Caregiver depression measured using the Hospital Anxiety and Depression Scale (HADS)

  At baseline, and after 6 months, 12 and 24 months from baseline

• Behavioural and psychological symptoms of dementia (BPSD) using the Neuropsychiatric Inventory (NPI)

  At baseline, and after 6 months, 12 and 24 months from baseline

• BPSD using the Revised Memory and Behaviour Checklist (RMBC)

  At baseline, and after 6 months, 12 and 24 months from baseline

• Patient quality-of-life measure with Logdson's Quality of Life AD

  At baseline, and after 6 months, 12 and 24 months from baseline

• Care-giver quality-of-life measure with Euro-Quality of Life

  At baseline, and after 6 months, 12 and 24 months from baseline

Study Arms (2)

Psychosocial Intervention

EXPERIMENTAL

Every caregiver in this arm will be assigned to a permanent counselor.

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.

Behavioral: Educational Intervention on AD

Interventions

Psychosocial Intervention BEHAVIORAL

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.

Psychosocial Intervention

Educational Intervention on AD BEHAVIORAL

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.

Educational Intervention on AD

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Azienda Sanitaria Locale N.1 dell'Umbria: lead
• Azienda Ospedaliera di Perugia: collaborator
• Azienda Ospedaliera di Terni: collaborator
• Azienda Unità Sanitaria Locale Umbria n. 2: collaborator

Study Sites (1)

USL Umbria 1

Perugia, 06127, Italy

RECRUITING

Related Publications (14)

• 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.

  PMID: 24618967 RESULT

• Alexopoulos 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.

  PMID: 3337862 RESULT

• Andren 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.

  PMID: 18606052 RESULT

• Binetti 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.

  PMID: 9561983 RESULT

• Brodaty 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.

  PMID: 12752841 RESULT

• Chattat 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.

  PMID: 21205379 RESULT

• Cuijpers P. Depressive disorders in caregivers of dementia patients: a systematic review. Aging Ment Health. 2005 Jul;9(4):325-30. doi: 10.1080/13607860500090078.

  PMID: 16019288 RESULT

• Cummings 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.

  PMID: 7991117 RESULT

• Joling 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.

  PMID: 22303473 RESULT

• Mittelman 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.

  PMID: 18978250 RESULT

• Mittelman 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.

  PMID: 17101889 RESULT

• Schulz 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.

  PMID: 10605972 RESULT

• Schulz 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.

  PMID: 15126224 RESULT

• Wimo 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.

  PMID: 20922346 RESULT

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alessandro Montedori, MD

  Regional Health Authority of Umbria

  STUDY CHAIR

Central Study Contacts

Serena Amici, MD, PhD

CONTACT

+393394384847; serena.amici@uslumbria1.it

Iosief Abraha, MD

CONTACT

+390755045251; iosief_a@yahoo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 6, 2016
• First Posted: February 19, 2016
• Study Start: April 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

IT (1)