The Talking Sense Communication Programme for Dementia Carers

NCT01481363 | Completed Phase 1 DMC

• 1 other identifier: UOP3203201
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

dementia; communication; carers; caregivers; psychosocial support systems; education

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the Hospital anxiety and depression scale (HADS) (Zigmund and Snaith, 1983)

  A carer self completed measure of anxiety and depression

  At ten weeks

Secondary Outcomes (3)

• Change from baseline in The Communication Competence Scale (Weimann et al, 1977)

  At ten weeks

• Change from baseline in The adult carer quality of life questionnaire (Elwick et al, 2010)

  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

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

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

The Talking Sense treatment

EXPERIMENTAL

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

Interventions

The Talking Sense manual BEHAVIORAL

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.

Also known as: Psychosocial intervention

The Talking Sense treatment

Treatment as usual - communication information and advice BEHAVIORAL

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.

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Portsmouth: lead
• Solent NHS Trust: collaborator
• The Sir Halley Stewart Trust: collaborator

Study Sites (1)

Speech and Language Therapy Department, Solent NHS Trust, St James Hospital,

Portsmouth, Hamsphire, PO48LD, United Kingdom

Location

MeSH Terms

Conditions

Dementia; Communication

Interventions

Psychosocial Intervention; Therapeutics; Counseling

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Mental Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Chris Markham, Ph.D.

  University of Portsmouth

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Speech and Language Therapist and PhD student, School of Health Sciences

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 29, 2011
• Study Start: March 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: March 1, 2014
• Last Updated: July 21, 2014

Record last verified: 2014-07

Locations

GB (1)