Dementia Mental and Behavioural Disorders
Conditions
Interventions
Methodology Justification:
This research study will follow the guidelines from the Medical Research Council (MRC) framework for the development of complex interventions
the process will be iterative. This study design has been chosen, as it was a priority of the researcher to ensure that experts by experience were key in the development and evaluation of the adapted
Sponsors
Sussex Partnership NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Focus Group Participants - Phases 1+ 4 (Co-Adapt and Co-evaluate) Family carers: 1. Lived experience of caring for a PLWD 2. Able to communicate in English 3. Age 18+ years old PLWD: 1. Lived experience of dementia 2. Able to communicate in English Clinicians: 1. Lived experience for working in an NHS clinical environment with PLWD 2. Able to communicate in English Trial Participants - Phases 2+3 (Single-Arm feasibility trial and data collection and analysis) PLWD: 1. Have received a clinical diagnosis of dementia 2. A score between 36 and 81 on the ACE III test 3. Have reported hallucinatory experiences 4. Have a family carer that can also participate in the intervention 5. Deemed to have capacity 6. Age 60-90 years old 7. Able to communicate in English Family carers 1. To be a family carer of someone who has had a clinical diagnosis of dementia 2. A minimum of 10 hours contact time per week with the PLWD (excluding time for meetings with lead researcher and the therapy sessions) 3. For their relative to also be able to participate in the intervention 4. To be able to participate in the intervention and engage with the materials outside of the clinical contact sessions 5. Able to communicate in English 6. Age 18+ years old
Exclusion criteria
Exclusion criteria: Focus Group Participants- Phases 1+ 4 (Co-Adapt and Co-evaluate) Family carer: 1. No lived experience of caring for a PLWD 2. Not able to communicate in English 3. Under age 18 years old PLWD: 1. No lived experience of dementia 2. Not able to communicate in English Clinicians: 1. No lived experience of working in an NHS clinical environment with PLWD 2. Not proficient in English Trial Participants - Phases 2+3 (Single-arm feasibility trial and data collection and analysis) PLWD: 1. No clinical dementia diagnosis 2. A score lower than 36 or higher than 81 on the ACE III test 3. No reports of hallucinatory experiences 4. Does not have a family carer that can participate in the intervention 5. Not deemed to have capacity 6. < 60 or 90< years old 7. Not able to communicate in English Family carer: 1. Not a family carer of someone who has had an official diagnosis of dementia 2. To have a less than 10 hours contact time per week with the PLWD (excluding time for meetings with lead researcher and the therapy sessions) 3. If their relative is not able to participate in the intervention 4. Not proficient in in English 5. Under age 18 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment Effectiveness: Demographic representativeness of recruited participants measured using an analysis of recruitment strategies and eligibility criteria after the recruitment phase 2. Participant Retention: Retention rate and reasons for attrition measured using an evaluation of retention strategies and analysis of attrition trends throughout the intervention period, with a final assessment at study completion 3. Intervention Completion and Exposure: The number of sessions attended by participants measured by monitoring attendance and engagement levels through session logs and exit interviews continuously throughout phases 2+3, with final analysis post-intervention 4. Intervention Acceptability: Participant feedback on acceptability measured using qualitative data through semi-structured exit interviews at the end of phases 2+3 5. Safety Monitoring: Incidence of adverse events and serious adverse events measured by auditing and monitoring adverse events with causality assessment continuously throughout the study, with final review at study completion | — |
Secondary
| Measure | Time frame |
|---|---|
| The research on the clinical outcome measures to be used in the single-arm feasibility trial has not been finalised, as the decisions will also depend on the conversations and discussions with focus group participants (family carers, PLWD and clinicians) in phase 1. The following suggested secondary outcome measures will be assessed at baseline and post-intervention: 1. Adaptation for Hallucinatory Experiences: The severity and frequency of hallucinatory experiences across all five senses measured using the Adapted Hamilton Program for Voices Questionnaire (HPSVQ). 2. Family Carer Quality of Life: The quality of life of family carers measured using the C-DEMQOL questionnaire 3. The Person with Dementia's Quality of Life: The quality of life of the person with dementia measured using the DEM-QOL questionnaire 4. Carer Burden: Level of burden experienced by the carer measured using the Zarit Carer Burden Interview 5. Depression Symptom Severity: The severity of depression symptoms measured using the PHQ-9 self-report measure 6. Anxiety Symptom Severity: Severity of anxiety symptoms measured using the GAD-7 measure | — |
Countries
England, United Kingdom
Contacts
Public ContactAmaani Al-Azzawi
Outcome results
None listed