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 :

* 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
B: Inclusion Criteria:

* Portuguese adults (≥18 years) (as self-reported and reported by professionals in the referral process);
* Giving consent to participate (Electronic Informed Consent);
* Providing non-paid care for at least 6 months at the time of the recruitment (as self-reported and reported by professionals in the referral process);
* Caring for a person holding a formal diagnosis of dementia (as reported by professionals in the referral process);
* Be skilled to use the internet (as self-reported and reported by professionals in the referral process);
* Experiencing either a clinically relevant level of subjective burden, as determined by a total score ≥ 21 on the Zarit Burden Interview or depression or anxiety symptoms, determined by a score ≥ 8 in at least one of the subscales of the Hospital Anxiety and Depression Scale.

Exclusion Criteria:

* Unable to comprehend written Portuguese (as reported by professionals in the referral process);
* Not having access to a device with internet connection at least twice a week (as self-reported and reported by professionals in the referral process);
* Declaring to care for a person in institutional care (e.g. nursing home or continued care unit) (as self-reported and reported by professionals in the referral process).
C: Inclusion Criteria:

General

* Age 21 years or older
* Ability to read, speak and understand English
* Home location within 50 miles of the study site Caregivers (CG)
* Active primary caregiver of a Person with Dementia (PwD) for at least 6 months and planning to remain the primary caregiver for the next 2 months
* Currently living with the PwD
* CG plans to live in the area for the duration of the study
* Is familiar and comfortable utilizing technology (e.g. computers, tablets, the internet)

Persons with Dementia (PwD)

* CG reports that the PwD exhibits at least one or more behavioral symptoms (any behavior at any frequency)
* PwD receiving psychotropic medication or cognitive enhancers will not be excluded.
* If PwD is on any of four classes of psychotropic medications (antidepressant, benzodiazepines, antipsychotic, or anti-convulsant) or an anti-dementia medication (memantine or a cholinesterase inhibitor), we will require that he/she have been on a stable dose for 60 days prior to enrollment (typical time frame in clinical trials) to minimize possible confounding effects of concomitant medications.
* Clinical diagnosis of dementia (any type) or a score of less than 24 on the Mini-Mental State Examination (MMSE)

Exclusion Criteria:

General

* Inability to read, speak or understand English
* Home location greater than 50 miles from the study site
* Lack of regular access to a telephone Caregivers (CG)
* Reading literacy of less than 6th grade
* Visual impairment to the extent of prohibiting interaction with the tool
* Hearing impairment sufficient to prohibit telephone communication
* Other self-identified mental or physical health issues that would distinctly interfere with the ability to reasonably test the tool or complete behavioral interventions (e.g. substance use disorder, schizophrenia, severe mobility issues)
* Hospitalized more than 3 times in the past year
* Participating in another study to help caregivers care for the person with dementia.

Persons with Dementia (PwD)

* At a terminal phase of illness, unable to respond to the environment or with a life expectancy less than 6 months
* Active suicide risk
* Imminent placement to nursing home (within the next 60 days)
* Hospitalized more than 3 times in the past year
* Currently in another study testing a medication to control behavioral symptoms
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