The TIMES-Route in practice with formal caregivers and residents in long-term care facilities

ISRCTN	ISRCTN84579696
DOI	https://doi.org/10.1186/ISRCTN84579696
Sponsors	University College Odisee, Stichting Alzheimer Onderzoek
Funders	University College Odisee, Stichting Alzheimer Onderzoek

Submission date: 01/12/2025
Registration date: 02/12/2025
Last edited: 02/12/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Melanie Van Bogaert
Principal investigator, Public, Scientific

University College Odisee, Campus Sint-Niklaas, Hospitaalstraat 23
9100 Sint-Niklaas
Belgium
Sint-Niklaas
9100
Belgium

ORCID ID	0009-0003-0621-0666
Phone	+32 3 776 43 48
Email	melanie.vanbogaert@odisee.be

Study information

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Parallel
Purpose	Supportive care
Scientific title	The TIMES-Route in practice with formal caregivers and residents in long-term care facilities: a pre-post study
Study objectives	In times of scarcity, we want to help care teams in residential care centers find more attention and time to provide emotional care to residents in long-term care facilities. Based on the experiences of care providers in residential care centers, a previous study developed the TIMES (Time Insights for More Emotional Support)-route: a toolbox consisting of four workshops and two peer review sessions that care teams go through together. The aim is for teams to rearrange their priorities based on reflection, knowledge, and thinking in terms of possibilities, and to devote more attention and time to emotional support for residents. With this research, we want to investigate the TIMES-route in practice among formal caregivers and residents in long-term care facilities. We want to investigate the impact of using this toolbox on the quality of life, pain behavior and changes in behavior and mood among residents. For formal caregivers, we focus on the sense of competence, psychological safety, self-efficacy, decision latitude and work demands and their perception on the quality of care and quality of emotional care they give. The hypothesis is that after the TIMES-route residents will have less mood and behavior changes (NPI), less symptoms of depression (Cornell Scale of Depression) and pain behavior ( DOLOPLUS-2) and will have an increase of scores on the quality of life (QUALIDEM). For the formal caregivers our hypothesis is that they will have an increase in self-efficacy, sense of competence, perception of care quality and quality of emotional care, psychological safety in their team and decision latitude. Based on the results of this research, we want to adapt the toolbox where necessary so that it can be used even more effectively in practice.
Ethics approval(s)	Approved 17/11/2025, Committee of Ethics Antwerp University Hospital (Drie Eikenstraat 655, 2630 Edegem, Edegem, 2630, Belgium; +32 38213000; ethisch.comite@uza.be), ref: B3002025000161
Health condition(s) or problem(s) studied	People living or working in a long-term care facility
Intervention	In this quantitative quasi -experimental pre-post study, formal caregivers of five teams from five different long-term care facilities will follow the TIMES-route with their team. All members of the team will attend four workshops. Six members of the team will participate in two 1.5h peer review sessions. The workshops and peer supervision sessions will be given by internal supervisors in three long-term care facilities. The two other facilities will have two external supervisors who will give the workshops and peer supervision sessions. All supervisors ( internal and external) will follow a two day train-the-trainer course, to be able to use the toolbox accordingly. Data is collected from the employees of the participating teams and from the residents of the ward where the team works. The data collection for this study is carried out using quantitative measuring instruments. The Neuropsychiatric Inventory (NPI), Cornell Scale of Depression in Dementia (CSDD), DOLOplus-2 and QUALIDEM are used for the residents. These observation questionnaires are completed for each resident by two different observers (members of the care team). A number of relevant demographic data are also requested from the residents (ea: age, gender, marital status, level of education, former occupation, length of stay in the residential care center, chronic conditions, use of psychotropic drugs, frequency of visits, participation in activities in the residential care center, KATZ score). Four questionnaires are administered to the employees of the participating teams: the General Self-efficacy Scale (GSES), the Psychological Safety Scale (PSS), Decision latitude and work demands, and the Sense of Competence in Dementia Care Staff Scale (SCIDS). Additionally three questions will assess the perception of quality of care and quality of emotional care of the ward where the caregivers work. A number of relevant demographic data are also requested from the employees (gender, age, discipline, level of education, years of service).The research will take place from December 2025 and will run until May 31, 2027. There are three moments of data collection. The first moment(T0) will take place before the team starts going through the toolbox as a baseline measurement. The second (T1) and third (T2) moments will take place during and after going through the toolbox, respectively. The completed questionnaires will be collected by an external supervisor or researcher. At the first moment of completing the observation questionnaires for the residents, a researcher will be available to support the observers if they have any questions.
Intervention type	Behavioural
Primary outcome measure(s)	Sense of competence in dementia measured using SCIDS at T0-T1-T2 Psychological Safety measured using Psychological Safety Scale ( Amy Edmondson) at T0-T1-T2 Decision lattitude and Work Intensity measured using Decision lattitude and work intensity questionnaire at T0-T1-T2 Self-efficacy measured using Dutch General Self-efficacy Scale at T0-T1-T2 Perception of quality of care and quality of emotional care measured using 3 questions with a scale from 0-10 at T0-T1-T2
Key secondary outcome measure(s)	Neuropsychiatric symptoms measured using Neuropsychiatric Inventory ( NPI) at T0-T1-T2 Symptoms of depression measured using Cornell Scale of Depression at T0-T1-T2 Quality of Life measured using QUALIDEM at T0-T1-T2 Pain Behavior measured using DOLOPLUS-2 at T0-T1-T2
Completion date	31/05/2027

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	110 Years
Sex	All
Target sample size at registration	170
Key inclusion criteria	1. Residents living in long-term care facilities 2. Formal caregivers of long-term care facilities
Key exclusion criteria	1. Temporary residents living in long-term care facilities
Date of first enrolment	01/12/2025
Date of final enrolment	31/12/2025

Locations

Countries of recruitment

Belgium

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

02/12/2025: Trial's existence confirmed by Committee of Ethics Antwerp University Hospital.