A Feasibility Study of a Psychosocial Intervention - The Talking Sense Communication Programme for Dementia Family Carers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change from baseline in the Hospital anxiety and depression scale (HADS) (Zigmund and Snaith, 1983)
研究概览
简要总结
Do family carers of people with dementia benefit from communication therapy and training? This study will only involve carers of people with dementia. Nearly all people with dementia will experience some difficulty communicating. Family carers of people with dementia have described communication and associated behaviour difficulties as one of the hardest to cope with.
This is a PhD study. The student/investigator has previously produced a detailed manual of approaches for supporting relatives of people with dementia who are experiencing communication difficulties. Previously published communication guides by other authors do not present research evidence.
Carers will be recruited to this study from the local NHS older person's mental health service overseen by their relative's psychiatrist. Only family carers will be included. Recruits will be randomly assigned to a treatment group or a control group. People in the control group will receive treatment as usual. The carers will be seen at home or at an NHS site if they prefer. The investigator and carer will work through the contents of the manual together. The manual is designed to consider their knowledge, thinking, skills and behaviour. The treatment will take no more than 4.5 hours over a period of up to 12 weeks.
Carers will be asked to complete questionnaires before and after the treatment. As well as background information, these questionnaires will look for any significant effects of the treatment on carers' anxiety and depression, carers' quality of life, carers' belief in their ability to care, communication difficulties experienced and the carers perceptions of their relatives communication competence.
A sample of 15 carers will also be interviewed by a third party interviewer who will be an existing speech and language therapy employee of Solent NHS Trust (see attached job description and person specification). The interviews will ask more specifically about their thoughts, feelings and opinions of this intervention and their experience in addressing communication difficulties.
详细描述
This is a feasibility study that intends to recruit 60 family carers over a period of up to 4 years. Carers will remain in the study for up to 12 weeks. They will be randomly assigned to a Talking Sense communication intervention and a treatment as usual control group of equal size. Quantitative and qualitative outcomes will be measured. Measures will include carer anxiety and depression, carer quality of life, carer general self efficacy and communication specific self efficacy as well as the carers rating of their relative's communication competence.
The null hypothesis for this study is that receiving the Talking Sense communication intervention would have no effect on carer reported depression, carer quality of life, carer's perception of their ability to cope with communication difficulties, carer reported experience of communication difficulties and carer reported person with dementia's communication competence. The alternative hypothesis suggests that one or more of these outcomes would be significantly greater for the treatment group in comparison to the control group.
This selection of outcome measures was identified by comparison with other treatment studies and in keeping with a theoretical framework for carer intervention studies described in a key text by Professor Richard Schulz, a prominent author in this field. Other longer term measures such as time to institutionalisation would be valuable though considered outside the remit of this study which is measuring short term effect only. If this feasibility study leads to a larger study, the longitudinal or wearing off of treatment effect would also be important to measure.
The ideal control group for this study would be carers receiving no treatment though this would be unethical. Comparison to another form of treatment e.g. a leaflet has been used in other studies though this introduces additional variables to account for. In this case treatment as usual is considered to be the most appropriate form of control condition.
Carers will be invited to participate in this study by a nurse or psychiatrist from the older person's mental health service. They will be asked if they wish to take a leaflet which broadly explains the purpose of the study and if their contact details can be passed to the chief investigator. All referrals will be approved by one of four overseeing psychiatrists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Carers will be included in this study if they are:
- •Spouses, co-habiting partners or children of the person with dementia in communication contact with their relative with dementia for more than two hours weekly.
- •Caring for a relative with a diagnosis of Alzheimer's disease, vascular dementia or lewy body dementia.
- •Reporting "existing difficulties with communication"
- •Demonstrating capacity to understand and consent to participation for the duration of the study
- •Considered suitable with particular attention to the carers mental wellbeing, by the overseeing or referring psychiatrist, for participating within this study.
- •Only receiving interventions within the parameters of treatment as usual as defined below.
- •Caring for a person with dementia with a recent score of between 21 and 27 out of 30 on the M.M.S.E. test (Folstein et al, 1975).
- •Carers demonstrating signs of anxiety and depression will not be excluded, due to its high prevalence, but will be screened as suitable for participation by the referring psychiatrist.
- •Although the Talking Sense manual is suitable for the widest range of communication difficulties in dementia, this study will limit its use to a cohort or people within the range of mild dementia as defined in the NICE clinical guidelines (2007). Using a more homogenous group of caregivers should improve generalisability of results. See also answer to question 6-
- •Treatment as usual will include medical, psychological and social treatments provided by health and social services including speech and language therapy for carers and people with dementia and informed by a modelling exercise of local services which is a separate objective of this Ph.D. study.
- •Carers considered to be receiving greater than standard treatment e.g. more than once weekly or other treatments focusing specifically on communication and behaviour or incorporating CBT will be excluded from participation in this study though will still be eligible for existing speech and language therapy services. It is expected that very few carers will be receiving greater than standard treatments.
排除标准
- •Carers will be excluded from participation if they:
- •Have not been approved for participation by an overseeing psychiatrist
- •Are caring for someone with a primary communication impairment associated with fronto-temporal dementia, Parkinson's disease or stroke as it is expected their presentation and experience will be significantly different.
- •Carers who have already received any significant form of individualised communication therapy e.g. with speech and language therapy or occupational therapy.
结局指标
主要结局
Change from baseline in the Hospital anxiety and depression scale (HADS) (Zigmund and Snaith, 1983)
时间窗: At ten weeks
A carer self completed measure of anxiety and depression
次要结局
- Change from baseline in The adult carer quality of life questionnaire (Elwick et al, 2010)(At ten weeks)
- Change from baseline in The Communication Competence Scale (Weimann et al, 1977)(At ten weeks)
- Change from baseline in The general self efficacy scale (Schwarzer and Jerusalem, 1995) with modifications to identify communication specific self efficacy(At ten weeks)
研究者
Mr COLIN BARNES
Principal Speech and Language Therapist and PhD student, School of Health Sciences
University of Portsmouth