TACIT trial (TAi ChI for people with demenTia)

Tools

Nyman, Samuel (2019) TACIT trial (TAi ChI for people with demenTia).

A randomised controlled trial comparing the effectiveness of tai chi alongside usual care with usual care alone on the postural balance of community-dwelling people with dementia: protocol for the TACIT trial (TAi ChI for people with demenTia)

Dataset Details

Research / Data Type:

Trial dataset

Creators:

Creators	Email
Nyman, Samuel	snyman@bournemouth.ac.uk

Groups:

Faculty of Health & Social Sciences

Collection period:

From	To
6 April 2017	17 July 2018

Date:

26 September 2019

Date type:

Publication

Data collection method:

From published protocol: Background: Falls are a public health issue for the older adult population and more so for people with dementia (PWD). Compared with their cognitively intact peers, PWD are at higher risk of falls and injurious falls. This randomised controlled trial aims to test the clinical and cost effectiveness of Tai Chi to improve postural balance among community-dwelling PWD and to assess the feasibility of conducting a larger definitive trial to reduce the incidence of falls among PWD. Methods: A 3-centre parallel group randomised controlled trial with embedded process evaluation. One hundred and fifty community-dwelling dyads of a person with dementia and their informal carer will be recruited and assessed at baseline and at six-month follow-up. Dyads will be randomised in a 1:1 ratio to either usual care or usual care plus a Tai Chi intervention for 20 weeks. The Tai Chi intervention will consist of weekly classes (45 min’ Tai Chi plus up to 45 min for informal discussion, with up to 10 dyads per class) and home-based exercises (20 min per day to be facilitated by the carer). Home practice of Tai Chi will be supported by the use of behaviour change techniques with the Tai Chi instructor at a home visit in week 3–4 of the intervention (action planning, coping planning, self-monitoring, and alarm clock reminder) and at the end of each class (feedback on home practice). The primary outcome is dynamic balance measured using the Timed Up and Go test, coinciding with the end of the 20-week intervention phase for participants in the Tai Chi arm. Secondary outcomes for PWD include functional balance, static balance, fear of falling, global cognitive functioning, visual-spatial cognitive functioning, quality of life, and falls. Secondary outcomes for carers include dynamic balance, static balance, quality of life, costs, and carer burden. Discussion: This trial is the first in the UK to test the effectiveness of Tai Chi to improve balance among PWD. The trial will inform a future study that will be the first in the world to use Tai Chi in a trial to prevent falls among PWD. Trial registration: NCT02864056.

Statement on legal, ethical and access issues:

Anonymised electronic records and paper copies of records will be open to inspection and monitoring from a recognised representative from either the Sponsor, Bournemouth University, the CTU, or the funder (National Institute for Health Research). The trial management group will have access to the full dataset. Other interested parties may make a formal request to access the electronic dataset, which will be approved / declined by the CI in accordance with the Data Management Plan that will detail management of access, sharing, and preservation of the data. Any use of the electronic data set must comply with the dissemination policy (see below) and be requested via Bournemouth University Library (bordar@bournemouth.ac.uk) who will collaborate with the CI with regards to access. Non-digital data supporting this study will be stored by the corresponding author at Bournemouth University. Only electronic data will be shared with bona fide researchers intending to use the data for non-commercial research purposes, after an embargo period of approximately 24 months. Access to the following will be restricted to researchers who sign a confidentiality agreement and confirm their intention to use the data is for secondary data analysis for non-commercial research purposes using a Creative Commons licence: statistical analysis plan; where applicable, statistical code (for final analysis of primary outcome measure); and anonymised participant-level dataset and data documentation.

Funder name(s):

National Institute for Health Research (NIHR)

Grant reference number(s):

CDF-2015-08-030

Keywords:

Accidental falls, Behaviour change, Caregiver, Clinical trial, Dementia, Exercise, Feasibility, Postural balance, Tai chi

Status:

Published

Publisher:

Dove Medical Press

Bournemouth University is the holder of the data.

Contact email address:

bordar@bournemouth.ac.uk

Record Details

DOI:	https://doi.org/10.18746/bmth.data.00000179
Depositing User:	Samuel Nyman
Year Deposited:	16 Nov 2021 15:33
Revision:	18
Last Modified:	16 Nov 2021 15:51

Available Files

Full Archive

SPSS working file_PDF.doc.pdf

Data

3. CSV file of dataset.csv | Request a copy

3. FINAL_TACIT_DATABASE.sav | Request a copy

Documentation

1. 209193_Study Prot ... ated_31.07.2018.docx

2. TACIT STATISTICAL ... ed-off Dec 2018.docx

Related Resources

Randomised Cont ... e With Dementia

The TACIT Trial ... e with demenTia

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