Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-29 @ 8:18 PM
Study NCT ID:
NCT04452903
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2020-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Communication Enhancing Intervention to Improve Patients' Perception of Physiotherapy Consultations
Sponsor:
Ariel University
Organization:
Study Overview
Official Title:
A Communication Enhancing Intervention to Improve Patients' Perception of Physiotherapy Consultations: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to test the effectiveness of a single training session in communication skills at improving patients' perceptions of physiotherapy consultations.
Detailed Description:
Population: Physiotherapists Detail: Physiotherapists (n=30) who work at 'Clalit' institute's (public health management organization in Israel) at four physiotherapy clinics.
Intervention: A single session of training in consultation-based communication skills Detail: a 3-hour communication skill workshop, followed by a month-long period to assimilate and implement the new set of skills, with supervision available by phone from the trainers.
Comparison: No training Detail: The control group receives no extra training. Outcome: New patients' perception of consultations Detail: The Primary Outcome Measure is the Consultation-Based Reassurance Questionnaire (CRQ) The CRQ measures patients' perceptions of consultation. It consists of four subscales, each with three items: data-gathering, relationship-building, generic reassurance, and cognitive reassurance. The investigators are assessing change between two-time points (before and after the intervention). And also, the difference between study groups. This is collected twice: at baseline, and at follow up, from the intervention and control groups.
Type of Question: therapy Detail: The study tests whether a single training sessions can improve communication in consultations with physiotherapists.
Type of Study: RCT
Detail: Stage 1: Pre-randomization:
The physiotherapists (n=30) will hand out a Consultation-Based Reassurance Questionnaire (CRQ) in a sealed envelope to each eligible patient (age 18+) they receive for the first consultation in two weeks period. The patient will complete the questionnaire in private, post consultation, and place it in a closed box. The physiotherapist will recruit a minimum of five patients each (n\>150).
Baseline measures are: age, gender, pain area, chronicity, pain severity, disability, satisfaction from the consultation and the Consultation-Based Reassurance Questionnaire.
Stage 2: Randomization:
The process for randomization:
First, participating physiotherapists will be matched for gender, seniority, and quality of reassurance in every clinic. They will then be allocated into one of the two arms at random (1:1), according to a computer random number list.
Stage 3: Follow up:
After the intervention, both the intervention and control groups will again hand out the questionnaires (age, gender, pain area, chronicity, pain severity, disability, satisfaction from the consultation and the CRQ) to new eligible patients that arrive for the first consultation. The physiotherapist will recruit a minimum of ten patients each (total sample therefore n\> 300, minimum number per arm=150).
sample size The sample size was calculated with G\*Power 3.1.9.4 using the t-test family to detect the difference between two independent means (two groups). The input parameters were as follows: for a two-tailed test, assuming a medium effect size of 0.5, α=0.05, and β=0.95, the total sample size recommended was 210 participants. One hundred five participants in each study group (intervention and control).
Intervention: A single session of training in consultation-based communication skills Detail: a 3-hour communication skill workshop, followed by a month-long period to assimilate and implement the new set of skills, with supervision available by phone from the trainers.
Comparison: No training Detail: The control group receives no extra training. Outcome: New patients' perception of consultations Detail: The Primary Outcome Measure is the Consultation-Based Reassurance Questionnaire (CRQ) The CRQ measures patients' perceptions of consultation. It consists of four subscales, each with three items: data-gathering, relationship-building, generic reassurance, and cognitive reassurance. The investigators are assessing change between two-time points (before and after the intervention). And also, the difference between study groups. This is collected twice: at baseline, and at follow up, from the intervention and control groups.
Type of Question: therapy Detail: The study tests whether a single training sessions can improve communication in consultations with physiotherapists.
Type of Study: RCT
Detail: Stage 1: Pre-randomization:
The physiotherapists (n=30) will hand out a Consultation-Based Reassurance Questionnaire (CRQ) in a sealed envelope to each eligible patient (age 18+) they receive for the first consultation in two weeks period. The patient will complete the questionnaire in private, post consultation, and place it in a closed box. The physiotherapist will recruit a minimum of five patients each (n\>150).
Baseline measures are: age, gender, pain area, chronicity, pain severity, disability, satisfaction from the consultation and the Consultation-Based Reassurance Questionnaire.
Stage 2: Randomization:
The process for randomization:
First, participating physiotherapists will be matched for gender, seniority, and quality of reassurance in every clinic. They will then be allocated into one of the two arms at random (1:1), according to a computer random number list.
Stage 3: Follow up:
After the intervention, both the intervention and control groups will again hand out the questionnaires (age, gender, pain area, chronicity, pain severity, disability, satisfaction from the consultation and the CRQ) to new eligible patients that arrive for the first consultation. The physiotherapist will recruit a minimum of ten patients each (total sample therefore n\> 300, minimum number per arm=150).
sample size The sample size was calculated with G\*Power 3.1.9.4 using the t-test family to detect the difference between two independent means (two groups). The input parameters were as follows: for a two-tailed test, assuming a medium effect size of 0.5, α=0.05, and β=0.95, the total sample size recommended was 210 participants. One hundred five participants in each study group (intervention and control).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: