An interventional study of Psychosocial Intervention and Educational Intervention on AD in Alzheimer's Disease, sponsored by Azienda Sanitaria Locale N.1 dell'Umbria. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-02-19.
Sponsored by Azienda Sanitaria Locale N.1 dell'Umbria · Not applicable, Interventional, and Treatment
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.
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:
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:
Each session will focus on the following topic:
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.
3,766 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.
This study's planned enrollment of 230 is above the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.
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Exclusion Criteria:
Every caregiver in this arm will be assigned to a permanent counselor.
Behavioral: Psychosocial Intervention
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 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.
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.
Care-giver burden measured with Zarit Burden Inventory (ZBI)
Change from baseline of care-giver burden at 6 months
Time frame: ZBI evaluated at 6 months
Care-giver burden measured with ZBI
Change from baseline of care-giver burden at 12 months
Time frame: ZBI evaluated at 12 months
Care-giver burden measured with ZBI
Change from baseline of care-giver burden at 24 months
Time frame: ZBI evaluated at 24 months
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
Plan to share: Undecided
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