Please select the eligibility criteria that correspond to the clinical trial below.
Title: Talking Time: Telephone Support Groups for Informal Caregivers of People With Dementia: A Randomized Controlled Trial
Brief Summary: Caring for people with dementia (PwD) at home requires an enormous amount of time, organization and commitment. Therefore, informal caregivers (ICs), mainly relatives, of PwD often feel a high burden. Even though support groups on-site have shown positive effects on the subjective well-being and on the perceived social support of ICs, relatives either have no time or opportunity to leave the PwD alone or there are no support groups in the vicinity. The Talking Time project therefore aims to close this supply gap by providing structured telephone-based support groups in Germany for the first time. International studies have shown resulting benefits for ICs.

Methods/Design: The project will be evaluated in a cluster adjusted randomized controlled trial. The effects of the 3-months Talking Time intervention will be compared to a normal care group. Outcomes will be measured at two different times (baseline = T0, after 3 months =T1). The control group will receive the Talking Time intervention after T1.

ICs are eligible if they are 18 or older, have cared for the PwD for at least four hours on four days per week in the last six months. Exclusion criteria are psychiatric disorders of the IC.

Primary outcome of the effectiveness elevation is the subjective well-being of the relatives measured by the mental component of the SF-12. Secondary outcomes are the physical component summary of the SF-12, the Perceived Social Support Caregiver Scale, the Caregiver Reaction Scale and the Neuropsychiatric Inventory. For the process evaluation different quantitative and qualitative data sources will be collected addressing reach, fidelity, and dosage.


Options:
A: Inclusion Criteria:

* Patient living in community and ambulatory
* Patient has diagnosis of Alzheimer's disease
* Patient age 50-95
* Caregiver age 18-90
* Patient currently under treatment for Alzheimer's disease
* Patient and caregiver reside within 2 hours of Los Angeles
* Caregiver has home internet access
* Patient has close contact with caregiver

Exclusion Criteria:

* Patient lives in residential setting
* No family contact
* Acute illness or chronic disease in patient or caregiver
* Patient or caregiver plans to leave area within the year
B: Inclusion criteria :

* Family caregivers of AD patients DSM IV-TR (American Psychiatric Association 2004) or NINCDS/ADRDA (McKhann et al. 1984).
* Age: over 18 years old
* score 12 or over on the Perceived Stress Scale 14 items (PSS-14, Cohen) Need for information or help
* Sign informed consent

Exclusion criteria :

* Professional or paid caregiver
* Physical or mental disease incompatible with patient's management
* Impossibility to participate in the educational program
* Absence of perceived stress
* Ongoing psychotherapy or a similar program in parallel
C: The eligibility criteria refers to the dyad.

Inclusion Criteria:

* patient with a diagnosis of Alzheimer's Disease
* Mini-Mental State Examination (MMSE) patients score between 10 and 20
* patient living in the community
* presence of family caregiver

Exclusion Criteria:

* lack of informed consent from the Alzheimer's patient or caregiver. If the patient has been declared legally incompetent or has a support administrator appointed, informed consent will be requested from a family member or from a person appointed by a judge. In the case of natural incapacitation, verified by Alzheimer Evaluation Unit doctors, consent for the patient will be requested from the primary caregiver;
* the presence of more severe diseases in addition to Alzheimer's or unstable chronic conditions in both the AD patient and the family caregiver, as assessed by the Alzheimer Evaluation Unit and other professionals in the health district-intention of moving out of the health district within 12 months;
* lack of a family caregiver or a caregiver less than 18 years old
D: Inclusion Criteria:

* medical ICD-10 dementia diagnosis available for the patient (F00.-\*: Alzheimer disease or related disorders, F01.-: Vascular dementia, F03.-:Unspecified dementia)
* living with or sharing cooking facilities with the care recipient or providing care for a relative with diagnosed Alzheimer disease or related disorders for at least 4 hours on at least 4 days of a week for at least the past 6 months, respectively
* access to a telephone connection to be able to participate in the talking Time Intervention and the telephone- based interviews for the evaluation

Exclusion Criteria:

* lack of knowledge of German Language of informal caregiver
* risk of suicide in the informal caregiver
* actual psychiatric diagnosis of mental illness of the caregiver
* ICD-10-diagnosis of Dementia in other diseases classified elsewhere (F02.-\*), except Dementia in Primary Parkinson disease (F02.3\*) and Lewy Body disease (F02.8/G31.82)

Answer: D