Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02655003
• Date of registration: 06/01/2016
• Prospective Registration: Yes
• Primary sponsor: Sykehuset Innlandet HF
• Public title: Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms TIME
• Scientific title: TIME - Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms
• Date of first enrolment: January 7, 2016
• Target sample size: 229
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02655003
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Sverre Bergh, PhD
• Affiliation: [phone]

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Clinical Dementia Rating scale (CDR) 1 or higher.

2. Moderate to high grade of agitation defined by the NPI-NH agitation item as equal to
or above six points.

3. Planned long-term stay in the nursing home, and a minimum of two weeks stay in the
nursing home before inclusion.

Exclusion Criteria:

1.Terminal phase (life expectancy less than 4-6 weeks)



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Dementia

Intervention(s)

Other: Education-only intervention

Other: TIME

Primary Outcome(s)

NPI-NH agitation/aggression [Time Frame: 8 weeks and 12 weeks]

Secondary Outcome(s)

CMAI [Time Frame: 8 weeks and 12 weeks]

Drug usage [Time Frame: 8 weeks and 12 weeks]

The Cornell scale for depression in dementia CSDD [Time Frame: 8 weeks and 12 weeks]

The NPI-NH caregiver occupational disruptiveness score [Time Frame: 8 weeks and 12 weeks]

NPI-NH sub syndrome affective symptoms [Time Frame: 8 weeks and 12 weeks]

NPI-NH sub syndrome psychosis [Time Frame: 8 weeks and 12 weeks]

General medical health using the General Medical Health Rating scale [Time Frame: 8 weeks and 12 weeks]

NPI-NH all separate items [Time Frame: 8 weeks and 12 weeks]

NPI-NH sub syndrome agitation [Time Frame: 8 weeks and 12 weeks]

Lawton and Brody ADL scale [Time Frame: 8 weeks and 12 weeks]

NPI-10 NH sum score [Time Frame: 8 weeks and 12 weeks]

Quality of life measured by the scale QUALID [Time Frame: 8 weeks and 12 weeks]

Secondary ID(s)

150333

Source(s) of Monetary Support

Please refer to primary and secondary sponsors