Early Counseling and Support for Alzheimer's Disease Caregivers (D_CareGiver)

February 18, 2016 updated by: Serena Amici, Azienda Sanitaria Locale N.1 dell'Umbria

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  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.

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:

  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:

  1. diagnosis and treatment,
  2. cognitive deficit management,
  3. behavioral disturbance management,
  4. daily living management,
  5. non-pharmacological treatment,
  6. 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 Type

Interventional

Enrollment (Anticipated)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Perugia, Italy, 06127
        • Recruiting
        • USL Umbria 1
        • Contact:
        • Sub-Investigator:
          • Alberto Trequattrini, MD
        • Sub-Investigator:
          • Mariangela Maiotti, MD
        • Sub-Investigator:
          • Annalaura Spinelli, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Psychosocial Intervention
Every caregiver in this arm will be assigned to a permanent counselor.
Behavioral: Psychosocial Intervention
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.
ACTIVE_COMPARATOR: Educational Intervention on AD
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
ZBI evaluated 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
ZBI evaluated 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
ZBI evaluated at 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
At baseline, and after 6 months, 12 and 24 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Sanitaria Locale N.1 dell'Umbria

Collaborators

Azienda Ospedaliera di Perugia
Azienda Ospedaliera di Terni
Azienda Unità Sanitaria Locale Umbria n. 2

Investigators

  • Study Chair: Alessandro Montedori, MD, Regional Health Authority of Umbria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ANTICIPATED)

January 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

February 6, 2016

First Submitted That Met QC Criteria

February 18, 2016

First Posted (ESTIMATE)

February 19, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR-2009-1607340

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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