The Talking Sense Communication Programme for Dementia Carers
|ClinicalTrials.gov Identifier: NCT01481363|
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : July 21, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Behavioral: The Talking Sense manual Behavioral: Treatment as usual - communication information and advice||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study of a Psychosocial Intervention - The Talking Sense Communication Programme for Dementia Family Carers|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||March 2014|
Active Comparator: Treatment as usual
Half of participants recruited will be randomly assigned to the control group to receive treatment as usual. This is will be based on a single one hour consultation which will include communication advice and information.
Behavioral: Treatment as usual - communication information and advice
Carers will receive the existing model of support provided by the speech and language therapy service. This is based on a one hour visit during which questions will be answered and specific advice given. No leaflets or manual will be used.
Experimental: The Talking Sense treatment
Half of carer participants recruited will be randomly assigned to receive the Talking Sense treatment. This will be conducted one to one and individualised over 3 sessions and no more than 4.5 hours during no more than 8 weeks.
Behavioral: The Talking Sense manual
Talking Sense is a recently written therapy manual for professionals to use with carers of people with dementia. It is intended to be used one to one with carers and is individualisable according to their relatives degree of communication difficulty or the extent to which the carer experiences difficulty with communication. The approach addresses the carers knowledge, skills, thinking and behaviour in a series of interdependent steps. In this study it will be delivered to carers during 3 home visits and up to a total of 4.5 hours.
Other Name: Psychosocial intervention
- Change from baseline in the Hospital anxiety and depression scale (HADS) (Zigmund and Snaith, 1983) [ Time Frame: At ten weeks ]A carer self completed measure of anxiety and depression
- Change from baseline in The Communication Competence Scale (Weimann et al, 1977) [ Time Frame: At ten weeks ]A carer self completed questinonaire rating the carers' perception of their relatives communication competence.
- Change from baseline in The adult carer quality of life questionnaire (Elwick et al, 2010) [ Time Frame: At ten weeks ]A recently published scale developed specifically for carers. This is self completed by carers to judge their own quality of life.
- Change from baseline in The general self efficacy scale (Schwarzer and Jerusalem, 1995) with modifications to identify communication specific self efficacy [ Time Frame: At ten weeks ]The general self efficacy scale is a published scale which will be completed alone carers. An additional scale has been developed to identify communication specfiic self-efficacy as no published scale was availalble This has been based on communication issues identified by carers during the development of the Talking Sense trial and has undergone an evaluation of face and content validity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481363
|Speech and Language Therapy Department, Solent NHS Trust, St James Hospital,|
|Portsmouth, Hamsphire, United Kingdom, PO48LD|
|Study Director:||Chris Markham, Ph.D.||University of Portsmouth|