Please select the arm or intervention descriptions that belong 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: Arm Label: caregiver website support; Type: EXPERIMENTAL; Interventions: Behavioral: caregiver website support | Arm Label: caregiver brief supportive phone calls; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: caregiver brief supportive phone calls | Intervention Type: BEHAVIORAL; Name: caregiver website support; Assigned to Arm(s): caregiver website support | Intervention Type: BEHAVIORAL; Name: caregiver brief supportive phone calls; Assigned to Arm(s): caregiver brief supportive phone calls
B: Arm Label: Psycho-educational program; Type: EXPERIMENTAL; Interventions: Behavioral: psycho-social intervention based on a web-based psycho-educational program, called Diapason. | Arm Label: Standard treatment; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Consultation in memory clinic | Intervention Type: BEHAVIORAL; Name: psycho-social intervention based on a web-based psycho-educational program, called Diapason.; Assigned to Arm(s): Psycho-educational program | Intervention Type: BEHAVIORAL; Name: Consultation in memory clinic; Assigned to Arm(s): Standard treatment
C: Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Other: light support, Other: 3 preventive home visits by a nurse | Arm Label: UP Protocol; Type: EXPERIMENTAL; Interventions: Other: Case Manager, Other: 3 preventive home visits by a nurse | Arm Label: UP-TECH Protocol; Type: EXPERIMENTAL; Interventions: Other: Case Manager, Other: Assistive Technologies, Other: 3 preventive home visits by a nurse | Intervention Type: OTHER; Name: Case Manager; Assigned to Arm(s): UP Protocol, UP-TECH Protocol | Intervention Type: OTHER; Name: Assistive Technologies; Assigned to Arm(s): UP-TECH Protocol | Intervention Type: OTHER; Name: light support; Assigned to Arm(s): Usual Care | Intervention Type: OTHER; Name: 3 preventive home visits by a nurse; Assigned to Arm(s): UP Protocol, UP-TECH Protocol, Usual Care
D: Arm Label: intervention; Type: EXPERIMENTAL; Interventions: Other: structured support groups | Arm Label: control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: structured support groups; Assigned to Arm(s): intervention

Answer: D