Cognitive Model for Behavioral Interventions as a Non-pharmacological Intervention for Behavioral and Psychological Symptoms of Dementia

Condition(s) studied

Investigational drug(s) / intervention(s)

CoMBI: CoMBI describes a four-step approach. First, the primary caregiver systematically observes and assesses the resident's BPSD using the NPI-Q. Second, the person's core needs are identified. An informant completes the PID-5-BF+M. The results of the PID-5-BF+M together with the overview of the different personality types, help identify the resident's core needs. Third, the care team selects one core need based on the most prominent and challenging BPSD. They choose a maximum of three interventions, which can focus on the substantive contact, attitude and environment of the resident. Finally, The selected interventions are further specified and personalized so that they are appropriate for the person with dementia, taking into account their life history This is documented in a CoMBI care plan, specifying which interventions will be applied and the desired behavioral outcomes.

Study summary

The goal of this study is to evaluate whether the Cognitive Model for Behavioral Interventions (CoMBI), a person-centered, non-pharmacological intervention, can reduce behavioral and psychological symptoms of dementia (BPSD) in people with dementia living in nursing homes. The study also aims to examine whether CoMBI can reduce caregiver burden and improve quality of life in people with dementia.

The main questions it aims to answer are:

Does CoMBI reduce the severity of behavioral and psychological symptoms of dementia compared to care as usual?

Does a reduction in BPSD lead to lower caregiver burden and improved quality of life for people with dementia?

Do personal factors, such as personality (dys)functioning, gender, level of cognitive impairment and stage of dementia, influence the effectiveness of CoMBI?

Researchers will compare CoMBI to care as usual to determine whether CoMBI leads to better outcomes for people with dementia and their caregivers.

Participants will:

Receive care in residential long-term care facilities where care staff are trained to apply CoMBI.

Be observed and assessed repeatedly over time as part of a stepped-wedge cluster randomized trial design.

Eligibility

Primary outcome measure(s)

• Neuropsychiatric Inventory - Questionnaire (NPI-Q) — Before the start of CAU, before the start of CoMBI and after four weeks of CoMBI training.
  The Neuropsychiatric Inventory - Questionnaire (NPI-Q) (de Jonghe et al., 2003; Kaufer et al., 2000) is a validated informant evaluation of BPSD measuring severity (rating 0-3) and caregiver distress (0-5) of 12 BPSD domains (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturb-ance, nighttime behaviors, appetite/eating).
• Qualidem — Before the start of CAU, before the start of CoMBI and after four weeks of CoMBI training.
  The Qualidem (Ettema et al., 2007) is a forty-item validated behavior observation-scale for patients (i.e. nursing homes) with up to severe dementia and can be administered in 15 minutes. Nine sub-scales (care relationship, positive affect, negative affect, restless tense behavior, positive self-image, social relations, social isolation, feeling at home, having something to do) provide a QoL-profile that can be used to evaluate the effects of intervention.

Trial sites (1)

More Vrije Universiteit Brussel trials in Belgium