Survey of Inpatients on Integrative Therapy Methods

April 18, 2023 updated by: ARCIM Institute Academic Research in Complementary and Integrative Medicine

Patient Survey on Integrative Therapy Methods - a Cross-sectional Study of Hospital Inpatients

Observational study of general patient satisfaction and inpatients' experiences with integrative therapies. The study recruits inpatients of the Filderklinik, an anthroposophic hospital in southwestern Germany. The aim is to assess overall patient satisfaction and inpatients' experiences with integrative therapies at the Filderklinik.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a cross-sectional study to investigate general patient satisfaction and inpatients' experiences with integrative therapies in an anthroposophic hospital. Participants will be recruited at the Filderklinik, a hospital in southwestern Germany that uses anthroposophic medicine (AM) on a broad basis. Inpatients who have received at least 10 treatments with one or more of the different integrative therapy methods will be asked for their willingness to participate. After providing written informed consent, participants will complete a questionnaire on integrative therapies received and overall patient satisfaction. In addition, data from the clinic database will be analyzed and cross-checked with the questionnaire data to verify and specify information about the participating sample. The focus of the study is to assess general patient satisfaction and experience with integrative therapy methods among inpatients at the Filderklinik.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
127

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • Baden-Württemberg
      • Filderstadt, Baden-Württemberg, Germany, 70794
        • ARCIM Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Inpatients of the Filderklinik who have received at least 10 treatments with one or more of the various integrative therapy methods used at the Filderklinik.

Description

Inclusion Criteria:

  • Written informed consent
  • Filderklinik inpatient who had at least 10 treatments with one ore more of the integrative therapy methods
  • Age 18 years or older

Exclusion Criteria:

  • Insufficient German language skills
  • Legally incapacitated patients
  • Patients who are physically incapable of giving written consent
  • Patients in isolation wards

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction, ZUF-8 total score
Time Frame: Assessing the entire duration of the hospital stay, an average of 7 days.
Patient satisfaction, measured with the ZUF-8 patient satisfaction questionnaire, a validated questionnaire (German language) with 8 items related to overall patient satisfaction associated with an inpatient hospital stay. Items are rated on 4-point scales from positive to negative (no "neutral" position), with 1 being the least positive and 4 being the most positive value (total scale range 8-32). In the current study, the ZUF-8 is part of the comprehensive "Special Therapy Procedures" questionnaire, which covers all outcome measures not retrieved from the clinic database.
Assessing the entire duration of the hospital stay, an average of 7 days.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diagnoses
Time Frame: Assessing the entire duration of the hospital stay, an average of 7 days.
Diagnoses of each patient documented in the clinic database.
Assessing the entire duration of the hospital stay, an average of 7 days.
Therapies
Time Frame: Assessing the entire duration of the hospital stay, an average of 7 days.
Therapies that were prescribed to each patient, as documented in the clinic database.
Assessing the entire duration of the hospital stay, an average of 7 days.
OPS codings
Time Frame: Assessing the entire duration of the hospital stay, an average of 7 days.
OPS codings for each patient documented in the clinic database. OPS = Operationen- und Prozedurenschlüssel, German modification of the ICPM (International Classification of Procedures in Medicine).
Assessing the entire duration of the hospital stay, an average of 7 days.
Inpatient admitting department
Time Frame: At the time of admission to the Filderklinik, at the beginning of hospitalization (an average of 7 days).
Department of the Filderklinik to which the patient was admitted for the inpatient stay.
At the time of admission to the Filderklinik, at the beginning of hospitalization (an average of 7 days).
Integrative therapies according to clinic database
Time Frame: Assessing the entire duration of the hospital stay, an average of 7 days.
Integrative therapies that were prescribed to each patient, as documented in the clinic database.
Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with music therapy
Time Frame: Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with the music therapy prescribed to them, assessed with the "Special Therapy Procedures" questionnaire. The questionnaire records general patient satisfaction and patient experience with the integrative therapy methods at the Filderklinik and asks for aspects of organization and procedure as well as the therapy itself. Answers are given on a 5-point Likert scale ranging from "I fully agree" to "I fully disagree", with "I fully agree" representing positive ratings.
Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with therapeutic painting
Time Frame: Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with the therapeutic painting prescribed to them, assessed with the "Special Therapy Procedures" questionnaire. The questionnaire records general patient satisfaction and patient experience with the integrative therapy methods at the Filderklinik and asks for aspects of organization and procedure as well as the therapy itself. Answers are given on a 5-point Likert scale ranging from "I fully agree" to "I fully disagree", with "I fully agree" representing positive ratings.
Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with therapeutic sculptural forming
Time Frame: Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with the therapeutic sculptural forming prescribed to them, assessed with the "Special Therapy Procedures" questionnaire. The questionnaire records general patient satisfaction and patient experience with the integrative therapy methods at the Filderklinik and asks for aspects of organization and procedure as well as the therapy itself. Answers are given on a 5-point Likert scale ranging from "I fully agree" to "I fully disagree", with "I fully agree" representing positive ratings.
Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with speech therapy
Time Frame: Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with the speech therapy prescribed to them, assessed with the "Special Therapy Procedures" questionnaire. The questionnaire records general patient satisfaction and patient experience with the integrative therapy methods at the Filderklinik and asks for aspects of organization and procedure as well as the therapy itself. Answers are given on a 5-point Likert scale ranging from "I fully agree" to "I fully disagree", with "I fully agree" representing positive ratings.
Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with eurythmy therapy
Time Frame: Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with the eurythmy therapy prescribed to them, assessed with the "Special Therapy Procedures" questionnaire. The questionnaire records general patient satisfaction and patient experience with the integrative therapy methods at the Filderklinik and asks for aspects of organization and procedure as well as the therapy itself. Answers are given on a 5-point Likert scale ranging from "I fully agree" to "I fully disagree", with "I fully agree" representing positive ratings.
Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with rhythmical massage
Time Frame: Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with the rhythmical massage prescribed to them, assessed with the "Special Therapy Procedures" questionnaire. The questionnaire records general patient satisfaction and patient experience with the integrative therapy methods at the Filderklinik and asks for aspects of organization and procedure as well as the therapy itself. Answers are given on a 5-point Likert scale ranging from "I fully agree" to "I fully disagree", with "I fully agree" representing positive ratings.
Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with external applications
Time Frame: Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with the external applications prescribed to them, assessed with the "Special Therapy Procedures" questionnaire. The questionnaire records general patient satisfaction and patient experience with the integrative therapy methods at the Filderklinik and asks for aspects of organization and procedure as well as the therapy itself. Answers are given on a 5-point Likert scale ranging from "I fully agree" to "I fully disagree", with "I fully agree" representing positive ratings.
Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with coloured light therapy
Time Frame: Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with the coloured light therapy prescribed to them, assessed with the "Special Therapy Procedures" questionnaire. The questionnaire records general patient satisfaction and patient experience with the integrative therapy methods at the Filderklinik and asks for aspects of organization and procedure as well as the therapy itself. Answers are given on a 5-point Likert scale ranging from "I fully agree" to "I fully disagree", with "I fully agree" representing positive ratings.
Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with the timing of integrative therapies
Time Frame: Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with the timing of the integrative therapies prescribed to them, assessed with the "Special Therapy Procedures" questionnaire. The questionnaire records general patient satisfaction and patient experience with the integrative therapy methods at the Filderklinik and asks for aspects of organization and procedure as well as the therapy itself. Answers are given on a 5-point Likert scale ranging from "I fully agree" to "I fully disagree", with "I fully agree" representing positive ratings.
Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with therapy plan communication
Time Frame: Assessing the entire duration of the hospital stay, an average of 7 days.
Patient experience with communication about the therapy plan that was set up for them, assessed with the "Special Therapy Procedures" questionnaire. The questionnaire records general patient satisfaction and patient experience with the integrative therapy methods at the Filderklinik and asks for aspects of organization and procedure as well as the therapy itself. Answers are given on a 5-point Likert scale ranging from "I fully agree" to "I fully disagree", with "I fully agree" representing positive ratings.
Assessing the entire duration of the hospital stay, an average of 7 days.
Difference in patient satisfaction: prior experience with AM vs. no prior experience with AM
Time Frame: Assessing the entire duration of the hospital stay, an average of 7 days.
Difference in patient satisfaction between the group of patients who had prior experience with AM and the group who had no prior experience with AM, measured with the ZUF-8 questionnaire. ZUF = "Zufriedenheit" = satisfaction. ZUF-8 = patient satisfaction questionnaire, a validated questionnaire (German language) with 8 items related to overall patient satisfaction associated with an inpatient hospital stay. Items are rated on 4-point scales from positive to negative (no "neutral" position), with 1 being the least positive and 4 being the most positive value (total scale range 8-32).
Assessing the entire duration of the hospital stay, an average of 7 days.
Difference in patient satisfaction: Filderklinik chosen for treatment with AM vs. Filderklinik chosen for other reasons
Time Frame: Assessing the entire duration of the hospital stay, an average of 7 days.
Difference in patient satisfaction between the group of patients who chose the Filderklinik because they request treatment with AM and the group who chose the Filderklinik for other reasons, measured with the ZUF-8 questionnaire. ZUF = "Zufriedenheit" = satisfaction. ZUF-8 = patient satisfaction questionnaire, a validated questionnaire (German language) with 8 items related to overall patient satisfaction associated with an inpatient hospital stay. Items are rated on 4-point scales from positive to negative (no "neutral" position), with 1 being the least positive and 4 being the most positive value (total scale range 8-32).
Assessing the entire duration of the hospital stay, an average of 7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jan Vagedes, Dr, ARCIM Institute Academic Research in Complementary and Integrative Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PAT_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.

IPD Sharing Time Frame

The data will be made available upon publication for a duration of three months.

IPD Sharing Access Criteria

The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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