NCT03208517

Brief Summary

The primary objective of this study is to determine whether a Person Centred Care online training programme confers significant benefit in terms of improving staff attitudes and quality of care of residents with dementia living in care homes, in comparison to enhanced usual training for professional care staff. There is considerable interest in e-learning and dementia from care home providers. Significant investment has been made into the production of resources for care staff but to date there appears to be no, or very limited, evaluation of their effectiveness. The aim is to provide a cost-effective, simple and practical evidence-based intervention, improving staff attitudes towards residents with dementia and quality of care provision. The trial will be a randomized controlled 3-arm cluster single blind trial that will take place over 9 months in 24 care homes in the UK.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

June 29, 2017

Last Update Submit

September 25, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Approaches to Dementia Questionnaire (ADQ) assessing change between time points

    This measure includes 19 attitudinal items, each scored from 1 (strongly disagree) to 5 (strongly agree) \[3\]. They are summed to form a total score (range 19-95) as well as a hope subscore (8 items, range 8-40) and a person-centred subscore (11 items, range 11-55). Higher scores indicate more positive attitudes. Example items indicative of hope (reverse scored) include ''people with dementia are very much like children'' and ''it is important not to become too attached to residents.'' Items related to person-centred care include ''it is important for people with dementia to be given as much choice as possible in their daily lives'' and ''people with dementia need to feel respected, just like anybody else.''

    T1: baseline, T2: up to 2 weeks post intervention, T3: 4 month follow up

Secondary Outcomes (6)

  • Dementia Care Mapping assessing change between time points

    T1: baseline, T2: up to 2 weeks post intervention, T3: 4 month follow up

  • The General Health Questionnaire-12 assessing change between time points

    T1: baseline, T2: up to 2 weeks post intervention, T3: 4 month follow up

  • Staff Experience Working with Residents with Dementia assessing change between time points

    T1: baseline, T2: up to 2 weeks post intervention, T3: 4 month follow up

  • Knowledge in Dementia Scale assessing change between time points

    T1: baseline, T2: up to 2 weeks post intervention, T3: 4 month follow up

  • Quality of Interactions Schedule assessing change between time points

    T1: baseline, T2: up to 2 weeks post intervention, T3: 4 month follow up

  • +1 more secondary outcomes

Study Arms (3)

Arm 1: Regular Contact Group (WHELD +)

EXPERIMENTAL

Regular Contact Group (WHELD elearning package + regular supervision support) A research associate will provide one face-to-face training session with participating care staff in the care home on how to use the online modules, providing a walk-through demonstration to ensure all are comfortable with the programme and its technology. The research associate will provide light touch support by returning fortnightly throughout the intervention period to the care home to observe/troubleshoot around online programme.

Other: Improving Wellbeing and Health for People with Dementia (WHELD) e-learning training programme

Arm 2: Online Contact Group (WHELD only)

EXPERIMENTAL

Online Contact Group (WHELD elearning package only) The e-learning modules will be emailed to the care home with clearly written instructions on how to access the course.

Other: Improving Wellbeing and Health for People with Dementia (WHELD) e-learning training programme

Arm 3: Enhanced usual practice Control Group

NO INTERVENTION

Arm 3: Enhanced usual practice Control Group (with information/signposting re high quality on line e-learning and educational materials). This will consist of a 2-page written guidance sheet on the best freely available dementia e-learning programmes and a one-off meeting with a research associate in the care home to explain the information/signposting

Interventions

The e-learning WHELD intervention The optimised e-learning programme will consist of five 25-minute interactive online modules based on a recently completed RCT of an in person training programme (WHELD), combining the most effective elements of existing approaches to create a comprehensive but practical staff training intervention. Based on a factorial study and qualitative evaluation, WHELD combines: person-centred care, person-centred activities and interactions, and updated knowledge regarding optimal use of psychotropic medications.

Arm 1: Regular Contact Group (WHELD +)Arm 2: Online Contact Group (WHELD only)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Care homes that have residential or nursing status and are registered to provide care for people with dementia.
  • Care homes randomly selected from the Care Home Research Network
  • Research enabled and actively engaged in ENRICH programme
  • Care homes should be able to demonstrate an acceptable standard of care according to Care Quality Commission (CQC).
  • Prepared to release staff to complete training and to implement interventions
  • Have a manager in post who is willing/able to act as key link person for trial
  • "Tech ready" home - staff have access to PCs or tablets in the care home

You may not qualify if:

  • Less than 60% of the residents have dementia
  • Care home is receiving special support from their local authority
  • Care home has failed to meet more than 1 of the 5 CQC care home quality standards checks
  • Insufficient staffing resource: Care home unable to provide care staff for training
  • Participant Selection:
  • Sufficient competence in English to undertake the training programme
  • Qualified and unqualified paid care staff
  • Permanent or contract employees providing direct care to residents
  • Has basic computer literacy
  • Bank or agency staff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, SE1 1UL, United Kingdom

Location

MeSH Terms

Conditions

Dementia

Interventions

Health

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Professor Clive Ballard

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 5, 2017

Study Start

May 1, 2016

Primary Completion

May 7, 2017

Study Completion

July 1, 2018

Last Updated

September 26, 2018

Record last verified: 2017-09

Locations