- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06476483
Feasibility and Acceptability of Implementing DIALOG+ in a Psychiatric Rehabilitation Unit
Implementing the DIALOG Outcome Measure and a Solution-Focused Intervention (DIALOG+) in a Rehabilitation Psychiatric Inpatient Setting: A Mixed Methods Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Yorkshire
-
Sheffield, South Yorkshire, United Kingdom, s35 0jw
- Forest Close
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 18-65
- Capacity to give informed consent as determined by the MDT and through following informed consent processes.
- Admitted into the inpatient ward
- Can complete DIALOG and DIALOG+
Exclusion Criteria:
- No capacity to consent
- Insufficient command of the English language
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: DIALOG
This is the comparison group, they will complete the DIALOG measure biweekly for 5 months.
DIALOG scores pre and post-intervention will be used in the analyses.
|
An outcome measure consisting of 11 questions, with 8 related to quality of life and 3 items on treatment satisfaction.
Patients can rate their satisfaction on a 7-point scale for each of the 8 life domains and 3 treatment aspects, resulting in scores for both quality of life and treatment satisfaction.
The DIALOG scale does not provide any guidance for patient and clinician interactions.
|
|
Active Comparator: DIALOG+
This is the treatment group.
The participants in this group have agreed to participate in DIALOG+ and will receive the intervention biweekly for 10 sessions (5 months).
Pre and post-intervention DIALOG scores will be used in the analysis.
|
A person-centred and solution-focused intervention linked to the DIALOG outcome measure (a measure of patient experience and quality of life).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility outcome- Recruitment rate/consent rate
Time Frame: assessed at the end of the study (after 5 months)
|
The number of people who agreed and consented to participate in the study out of the total number of eligible participants approached.
Reported as a percentage.
|
assessed at the end of the study (after 5 months)
|
|
Feasibility outcome- Number of eligible participants.
Time Frame: assessed at the end of the study (after 5 months)
|
Eligible participants are those who meet the inclusion criteria, reported as a count of participants.
|
assessed at the end of the study (after 5 months)
|
|
Feasibility outcome- Participation rate
Time Frame: assessed at the end of the study (after 5 months)
|
The proportion of those who consented and agreed to engage in DIALOG and DIALOG+ out of the number of participants who engaged in the intervention after consenting.
Reported as a percentage of participants.
|
assessed at the end of the study (after 5 months)
|
|
Feasibility outcome- Completion rate
Time Frame: assessed at the end of the study (after 5 months)
|
The proportion of those who completed the intervention out of the number who consented and engaged in DIALOG and DIALOG+.
Reported as a percentage of participants.
|
assessed at the end of the study (after 5 months)
|
|
Feasibility outcome- Drop out rate
Time Frame: assessed at the end of the study (after 5 months)
|
The number of participants who completed the intervention out of total number of patients enrolled.
Reported as a percentage of participants.
|
assessed at the end of the study (after 5 months)
|
|
Feasibility outcomes- Reasons for drop out
Time Frame: assessed at the end of the study (after 5 months)
|
Reasons for drop out will be assessed when by asking the participant after drop out.
|
assessed at the end of the study (after 5 months)
|
|
Feasibility outcomes- Follow up rate
Time Frame: assessed at the end of the study (after 5 months)
|
The number of patients willing to engage in follow-up surveys related to the study out of the total number of participants enrolled in the study.
Reported as a percentage of participants.
|
assessed at the end of the study (after 5 months)
|
|
Feasibility outcome- The willingness of clinicians to recruit participants
Time Frame: assessed at the end of the study (after 5 months)
|
Number of staff members who attend DIALOG+ training and implement intervention out of the total number of staff offered to participate.
Reported as a percentage.
|
assessed at the end of the study (after 5 months)
|
|
Feasibility outcome- Average number of DIALOG+ sessions
Time Frame: assessed at the end of the study (5 months)
|
Reported as the average number of participants.
|
assessed at the end of the study (5 months)
|
|
Acceptability outcome- Cost
Time Frame: assessed at the end of the study (after 5 months)
|
Analysing the cost and benefits of implementing the intervention (including staff training).
Reported as a total amount or duration of time spent on training (minutes).
|
assessed at the end of the study (after 5 months)
|
|
Number of staff participants who find DIALOG and DIALOG+ feasible and acceptable to implement in an inpatient rehabilitation setting. Assessed using thematic analysis of focus groups.
Time Frame: assessed at the end of the study (after 5 months)
|
To assess the acceptability of the intervention a theoretical framework (Sekhon et al., 2017) was used.
Feasibility objectives are defined by Bugge et al., 2013.
Focus group transcripts will be subject to a qualitative thematic analysis.
Analysis of focus groups will involve coding, organising coding into themes, reviewing themes, and generating a final thematic overview with in relation to the research question (Braun & Clarke, 2006).
|
assessed at the end of the study (after 5 months)
|
|
Number of patients who find it feasible and acceptable to implement DIALOG and DIALOG+ in an inpatient rehabilitation setting. Assessed using thematic analysis and average scores of patient surveys.
Time Frame: assessed at the end of the study (after 5 months)
|
The questionnaires will be a mixture of open ended questions and Likert Scale questions based on questions asked by Matanov et al. (2021), 8 of the questions are scored on a Likert scale (1-5).
The survey will be given to patients post-intervention.
Questions on the scale have been specifically developed to assess feasibility and acceptability of DIALOG+.
An average total score will be used in the analysis of Likert scale questions.
Open-ended questionnaire responses will be subject to a qualitative thematic analysis.
Analysis will involve coding, organising coding into themes, reviewing themes, and generating a final thematic overview in relation to the research question (Braun & Clarke, 2006).
|
assessed at the end of the study (after 5 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DIALOG questionnaire
Time Frame: At the beginning of the study, then biweekly for a duration of 5 months with the final measure taken after 5 months
|
The DIALOG questionnaire consists of 11 questions, with 8 items related to subjective quality of life (SQOL) and 3 items on treatment satisfaction. Patients can rate their satisfaction on a 7-point scale for each of the 8 life domains and 3 treatment aspects, resulting in scores for both SQOL and treatment satisfaction. An increase in score indicates improvement. The dependent variable will be DIALOG outcomes at the end of intervention or discharge and the independent variable will be the group binary variable (intervention or comparison group). Data will be analysed using a linear regression model to assess whether implementing DIALOG+ as an intervention in addition to using the DIALOG outcome measure, leads to improved outcomes. The unit of measure: reported as an average total score. |
At the beginning of the study, then biweekly for a duration of 5 months with the final measure taken after 5 months
|
|
Demographic information
Time Frame: assessed at the end of the study (5 months)
|
To gather demographic details from patients to assess the potential generalisability of DIALOG and DIALOG+.
• Demographic information includes age, gender, ethnicity, history of mental illness or previous inpatient admissions, drug-use, diagnosis, baseline severity on DIALOG, and length of stay.
Reported as a percentage of participants.
|
assessed at the end of the study (5 months)
|
|
Length of admission in months
Time Frame: assessed at the end of the study (5 months)
|
To use regression analysis to understand the effectiveness of the intervention and impact on admission length and DIALOG score.
|
assessed at the end of the study (5 months)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 187799
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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