OncologyNCT05493306
Evaluation of Telerehabilitation Following Inpatient or Outpatient Rehabilitation Phase II
An observational study of Oncology and Musculoskeletal Diseases, run by Pensionsversicherungsanstalt at 1 site in Austria.
Trial summary
Telerehabilitation is implemented in the Pensionsversicherungsanstalt (PVA) as an independent rehabilitation offer following a rehabilitation phase II. This offer primarily includes physiotherapeutic training units in group settings and in individual counselling, as well as health-related educational sessions and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oncology, Musculoskeletal Diseases
- How many people
- 126 participants
- Where
- 1 siteAustria
- Study dates
- 8 Apr 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have completed rehabilitation phase II and have been assessed by their doctor as suitable for telerehabilitation. Involved treatment team and administrative team.
Who may be able to join
- Patients who have completed rehabilitation (phase II) with the indications:
- musculoskeletal diseases
- oncology.
Who cannot join
- Failure to obtain the declaration of consent
- Lack of the required technical aids (mobile phone, tablet or PC)
- Lack of the technical skills to operate the app and thus to participate in telerehabilitation.
Trial locations and contacts
1 site in 1 country.
Austria1 site
PVA - Zentrum für ambulante Rehabilitation Graz
Graz, Styria, 8020
About this study
Official title: Evaluation Der Telerehabilitation im Anschluss an Eine stationäre Oder Ambulante Rehabilitation Phase II - Pilotprojekt [Evaluation of Telerehabilitation Following Inpatient or Outpatient Rehabilitation Phase II - Pilot Project]
Telerehabilitation is implemented in the Pensionsversicherungsanstalt (PVA) as an independent rehabilitation offer following a rehabilitation phase II. This offer primarily includes physiotherapeutic training units in group settings and in individual counselling, as well as health-related educational sessions and doctor's consultations via video conferencing, initially for rehabilitation patients with diseases of the musculoskeletal system or oncological diseases. The first stage of the implementation process was evaluated with a focus on acceptance, usability and feasibility from the perspective of patients and treatment team.
The evaluation was based on a convergent mixed methods design (Creswell \& Plano Clark, 2017) to draw on the strengths of qualitative and quantitative research approaches (Creswell \& Creswell, 2018). Qualitative and quantitative data were generated in parallel and treated equally. The perspective of the patients (N = 86) was collected through online questionnaires and in-depth telephone interviews (N = 22) and that of the treatment team through a questionnaire survey (N = 32) and focus group interviews (N = 24). The administrative team (N = 8) was asked for their assessment in a focus group interview. Technical difficulties in the implementation of telerehabilitation were documented by the treatment team. The consolidation of these multi-perspective results took place at the level of interpretation.
- Conditions
- Oncology, Musculoskeletal Diseases
- Keywords
- Telerehabilitation, Evaluation, Usability
- Medical subject headings
- Neoplasms, Musculoskeletal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the telerehabilitation
The patients' perspective was collected with a self-developed online questionnaire (N = 86) and in-depth telephone interviews (N = 22).
The questionnaires were analysed descriptively. The telephone interviews were protocolled and subsequently coded and categorised.
The perspective of the treatment team was collected with a self-developed questionnaire (N = 32) and focus group interviews (N = 24).
In addition, the administrative team (N = 8) was asked for their assessments in a focus group interview. The questionnaires were analysed descriptively. The focus group interview was recorded and subsequently coded and categorised.
Measured: April 2021 - May 2022
Feasibility of the telerehabilitation
Technical difficulties concerning the video calls were continuously documented by the treatment team. The data were analysed descriptively.
Measured: April 2021 - May 2022
Acceptance of the telerehabilitation
The patients' perspective was collected with a self-developed online questionnaire (N = 86) and in-depth telephone interviews (N = 22).
The questionnaires were analysed descriptively. The telephone interviews were protocolled and subsequently coded and categorised.
The perspective of the treatment team was collected with a self-developed questionnaire (N = 32) and focus group interviews (N = 24).
The questionnaires were analysed descriptively. The focus group interviews were recorded and subsequently coded and categorised.
Measured: April 2021 - May 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start8 Apr 2021
- Primary completion31 Mar 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pensionsversicherungsanstalt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Felder, Mag., Study chair, Pensionsversicherungsanstalt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493306
- Sponsor's protocol ID
- 0002 Evaluation Telereha
- Status last verified
- Jul 2022
- First submitted
- 5 Aug 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Der Telerehabilitation im Anschluss an Eine stationäre Oder Ambulante Rehabilitation Phase II - Pilotprojekt [Evaluation of Telerehabilitation Following Inpatient or Outpatient Rehabilitation Phase II - Pilot Project]
- ClinicalTrials.gov ID
- NCT05493306
- Acronym / sponsor ID
- 0002 Evaluation Telereha
- Conditions
- Oncology, Musculoskeletal Diseases
- Keywords
- Telerehabilitation, Evaluation, Usability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- PensionsversicherungsanstaltUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Telerehabilitation is implemented in the Pensionsversicherungsanstalt (PVA) as an independent rehabilitation offer following a rehabilitation phase II. This offer primarily includes physiotherapeutic training units in group settings and in individual counselling, as well as health-related educational sessions and doctor's consultations via video conferencing, initially for rehabilitation patients with diseases of the musculoskeletal system or oncological diseases. The first stage of the implementation process was evaluated with a focus on acceptance, usability and feasibility from the perspective of patients and treatment team.
The evaluation was based on a convergent mixed methods design (Creswell \& Plano Clark, 2017) to draw on the strengths of qualitative and quantitative research approaches (Creswell \& Creswell, 2018). Qualitative and quantitative data were generated in parallel and treated equally. The perspective of the patients (N = 86) was collected through online questionnaires and in-depth telephone interviews (N = 22) and that of the treatment team through a questionnaire survey (N = 32) and focus group interviews (N = 24). The administrative team (N = 8) was asked for their assessment in a focus group interview. Technical difficulties in the implementation of telerehabilitation were documented by the treatment team. The consolidation of these multi-perspective results took place at the level of interpretation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have completed rehabilitation phase II and have been assessed by their doctor as suitable for telerehabilitation. Involved treatment team and administrative team.
Key inclusion criteria (3 listed)
- musculoskeletal diseases
- oncology.
Key exclusion criteria (3 listed)
- Failure to obtain the declaration of consent
- Lack of the required technical aids (mobile phone, tablet or PC)
- Lack of the technical skills to operate the app and thus to participate in telerehabilitation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Usability of the telerehabilitation
Time frame: April 2021 - May 2022
The patients' perspective was collected with a self-developed online questionnaire (N = 86) and in-depth telephone interviews (N = 22). The questionnaires were analysed descriptively. The telephone interviews were protocolled and subsequently coded and categorised. The perspective of the treatment team was collected with a self-developed questionnaire (N = 32) and focus group interviews (N = 24). In addition, the administrative team (N = 8) was asked for their assessments in a focus group interview. The questionnaires were analysed descriptively. The focus group interview was recorded and subsequently coded and categorised.
Feasibility of the telerehabilitation
Time frame: April 2021 - May 2022
Technical difficulties concerning the video calls were continuously documented by the treatment team. The data were analysed descriptively.
Acceptance of the telerehabilitation
Time frame: April 2021 - May 2022
The patients' perspective was collected with a self-developed online questionnaire (N = 86) and in-depth telephone interviews (N = 22). The questionnaires were analysed descriptively. The telephone interviews were protocolled and subsequently coded and categorised. The perspective of the treatment team was collected with a self-developed questionnaire (N = 32) and focus group interviews (N = 24). The questionnaires were analysed descriptively. The focus group interviews were recorded and subsequently coded and categorised.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Felder, Mag. study chair
Pensionsversicherungsanstalt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology and Musculoskeletal Diseases, run by Pensionsversicherungsanstalt at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the telerehabilitation (time frame: April 2021 - May 2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.