Specialty: Dementias and neurodegeneration, Primary sub-specialty: Dementia
Conditions
Interventions
SHAPED-TF is designed in two phases:
Phase 1:
Investigates the efficacy and tolerability of non-drug approaches to treating visual hallucinations. All patients entering
Sponsors
King's College London
South London and Maudsley NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 60+ years old 2. Sufficient fluency in English to participate in the interviews 3. Clinical diagnosis of dementia, eye disease or Parkinson’s disease. 4. Experience of visual hallucinations every two weeks over the 4 weeks prior to trial entry. 5. MMSE > 13
Exclusion criteria
Exclusion criteria: Exclusion Phase 1 1. Visual hallucinations accounted for by schizophrenia, epilepsy or narcolepsy 2. Participation in an interventional clinical trial in the previous 28 days. 3. Patients with dementia without a study partner. Exclusion Phase 2 1. If prescribed a cholinesterase inhibitor as part of routine clinical care, contraindications or cautions to ondansetron (Congenital long QT syndrome; Adenotonsillar surgery; subacute intestinal obstruction; susceptibility to QT-interval prolongation (including electrolyte disturbances - see current summary of Product Characteristics)). 2. If not prescribed a cholinesterase inhibitor as part of routine clinical care, contra-indications or cautions to donepezil (Asthma; chronic obstructive pulmonary disease; sick sinus syndrome; supraventricular conduction abnormalities; susceptibility to peptic ulcers - see current Summary of Product Characteristics).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Hallucination phenomenology is measured using the North East Visual hallucination Interview (NEVH-I) as adapted for SHAPED-TF to record the frequency, duration and emotional impact of visual hallucinations at all time points 2. Patient views are measured using semi-structured questionnaires through interviews at various time-points. The semi-structured questionnaire about general views is administered at baseline and the semi-structured questionnaire about the non-medication strategy is administered at week 4. The semi-structured questionnaire about the medication is administered at week 6 (for those taking part in Stage 1 and Stage 2), and the semi-structured questionnaire about all the strategies in the study is administered at the last time-point (week 6 if only taking part in Stage 1, and week 8 if taking part in Stage 1 and Stage 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| In order to inform future trials, we will obtain effect size estimates for the two non-drug treatment approaches across various domains. These will include changes in hallucination phenomenology (hallucination frequency, duration and emotional impact in the groups) as measured by the NEVH-I at all time-points, and in therapeutic effect, quality of life, treatment satisfaction, wellbeing, carer wellbeing and cost-effectiveness: 1.1. Disease specific quality of life is measured using the disease-specific quality of life (DQoL) questionnaire administered at two time points: baseline and either week 4 (if only taking part in Stage 1) or week 6 (if taking part in Stage 1 and Stage 2) 1.2. Changes in treatment satisfaction are measured using the “general” treatment of “hallucinations” satisfaction questionnaires (“Hall”TSQ) administered at baseline and week 4 and week 6 (if taking part in Stage 2) and at the last time-point (week 4 if only taking part in Stage 1, and week 8 if taking part in Stage 1 and Stage 2) 1.3. Overall well-being in participants and study partners is measured using the 12-item well-being questionnaire (W-BQ12) at two time points: baseline and either week 4 (if only taking part in Stage 1) or week 6 (if taking part in Stage 1 and Stage 2) 1.4. Depression is measured using the geriatric depression scale (GDS) at two time points: baseline and either week 4 (if only taking part in Stage 1) or week 6 (if taking part in Stage 1 and Stage 2) 1.5. Health and social care service use information is assessed using the Client Service Receipt Inventory (CSRI) as adapted for SHAPED-TF, administered at two time points: baseline and either week 4 (if only taking part in Stage 1) or week 6 (if taking part in Stage 1 and Stage 2) 1.6 The EuroQol-5 dimension (EQ-5D) will also be used to provide a descriptive profile and single index value for health status, administered at | — |
Countries
United Kingdom
Contacts
Public ContactRebecca Pinto
Outcome results
None listed