How much information and participation is just right? An exploratory study of the need for autonomy in outpatient care of patients with inflammatory rheumatic diseases

How much information and participation is just right? An exploratory study of the need for autonomy in outpatient care of patients with inflammatory rheumatic diseases - Autonomy in rheumatic diseases

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011517

Enrollment

1000

Registered

2017-02-17

Start date

2017-01-18

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inflammatory rheumatic diseases L40.5 L93 M07 M08 M32 M33 M34 M35.0 M35.1 M05 M06.0 M45

Interventions

Group 1: First study phase: 400 members of a self-help group in Saxony-Anhalt will be asked to fill in a written questionnaire at one point in time. They answer questions about their need for particip

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: men and women at the age of 18 years and above with an inflammatory rheumatic disease (rheumatoid arthritis, spondylarthtiris, connective tissue disease)

Exclusion criteria

Exclusion criteria: deficient German language skills, insufficient writing skills

Design outcomes

Primary

Measure	Time frame
First study phase: - need for autonomy (Autonomy Preference Index; API) Second study phase (t1 and t2): - need for autonomy (Autonomy Preference Index; API)	—

Secondary

Measure	Time frame
First study phase: Secondary outcomes of the first study phase are: - pain (Numeric Rating Scale; NRS-10) - general health status (NRS-10) - fatigue (NRS-10) - functional status and quality of life (Arthritis Impact Measurement Scales; AIMS2) - depression (PHQ-8) - health literacy (HELP-questionnaire) - illness perception (Brief Illness Perception Questionnaire; BIPQ) Important treatment decisions and other disease-relevant topics are asked by self-administered questionnaires (incl. personal relevance, perceived information status, need for information, exchange and/or participation). As control variables in the first study phase the following variables are considered: - disease background (diagnosis, disease duration, comorbidity, body mass index, attending physicians) - socio-demographics (age, sex, social status, employment status) Second study phase: The following variables are assessed at baseline only (t1): - Shared Decision Making (MAPPIN’SDM; doctors' and patients' sheet) - disease background (diagnosis, disease duration, comorbidity, body mass index, further attending physicians) - socio-demographics (age, sex, social status, employment status) The following secondary outcomes are assessed at baseline (t1) and follow-up (t2): - patient satisfaction (ZUF-8) - pain (NRS-10) - general health status (NRS-10) - fatigue (NRS-10) - functional status and quality of life (Arthritis Impact Measurement Scales; AIMS2) - depression (PHQ-8) - health literacy (HELP-questionnaire) - illness perception (Brief Illness Perception Questionnaire; BIPQ) The following secondary outcome is assessed at follow-up (t2): - treatment adherence (Compliance Questionnaire for Rheumatology; CQR5)	—

Measure

Time frame

First study phase: Secondary outcomes of the first study phase are: - pain (Numeric Rating Scale; NRS-10) - general health status (NRS-10) - fatigue (NRS-10) - functional status and quality of life (Arthritis Impact Measurement Scales; AIMS2) - depression (PHQ-8) - health literacy (HELP-questionnaire) - illness perception (Brief Illness Perception Questionnaire; BIPQ) Important treatment decisions and other disease-relevant topics are asked by self-administered questionnaires (incl. personal relevance, perceived information status, need for information, exchange and/or participation). As control variables in the first study phase the following variables are considered: - disease background (diagnosis, disease duration, comorbidity, body mass index, attending physicians) - socio-demographics (age, sex, social status, employment status) Second study phase: The following variables are assessed at baseline only (t1): - Shared Decision Making (MAPPIN’SDM; doctors' and patients' sheet) - disease background (diagnosis, disease duration, comorbidity, body mass index, further attending physicians) - socio-demographics (age, sex, social status, employment status) The following secondary outcomes are assessed at baseline (t1) and follow-up (t2): - patient satisfaction (ZUF-8) - pain (NRS-10) - general health status (NRS-10) - fatigue (NRS-10) - functional status and quality of life (Arthritis Impact Measurement Scales; AIMS2) - depression (PHQ-8) - health literacy (HELP-questionnaire) - illness perception (Brief Illness Perception Questionnaire; BIPQ) The following secondary outcome is assessed at follow-up (t2): - treatment adherence (Compliance Questionnaire for Rheumatology; CQR5)

—

Countries

Germany

Contacts

Public ContactKatja Raberger

Institut für Rehabilitationsmedizin, Medzinische Fakultät der Martin-Luther-Universität Halle-Wittenberg

katja.raberger@medizin.uni-halle.de0345-557-7646

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026