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The Talking Sense Communication Programme for Dementia Carers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01481363
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : July 21, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study of a Psychosocial Intervention - The Talking Sense Communication Programme for Dementia Family Carers
Study Start Date : March 2012
Primary Completion Date : October 2013
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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 6-2.
    • 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.

Exclusion Criteria:

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481363

United Kingdom
Speech and Language Therapy Department, Solent NHS Trust, St James Hospital,
Portsmouth, Hamsphire, United Kingdom, PO48LD
Sponsors and Collaborators
University of Portsmouth
Solent NHS Trust
The Sir Halley Stewart Trust
Study Director: Chris Markham, Ph.D. University of Portsmouth
More Information

Responsible Party: Mr COLIN BARNES, Principal Speech and Language Therapist and PhD student, School of Health Sciences, University of Portsmouth
ClinicalTrials.gov Identifier: NCT01481363     History of Changes
Other Study ID Numbers: UOP3203201
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: July 21, 2014
Last Verified: July 2014

Keywords provided by Mr COLIN BARNES, University of Portsmouth:
psychosocial support systems

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders