Nurse-led immunotherapy decision coaching in persons with relapsing-remitting multiple sclerosis (DECIMS)

Nurse-led Immunotherapy DEcision Coaching In persons with relapsing-remitting Multiple Sclerosis (DECIMS) ? an evaluator-blinded cluster randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN37929939

Enrollment

300

Registered

2014-05-27

Start date

2014-06-09

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Multiple sclerosis Nervous System Diseases Multiple sclerosis

Interventions

Experimental intervention: One to three counselling (decision coaching) sessions with specially trained nurses, supported by an evidence-based online patient information tool prior to a decisional en

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with possible or relapsing-remitting MS within a decision-making process on beginning immunotherapy or changing immunotherapy to an oral treatment 2. Internet access

Exclusion criteria

Exclusion criteria: 1. Major psychiatric disease or severe cognitive deficit 2. Progressive disease courses of MS 3. Decision on escalation immunotherapy therapy (e.g. natalizumab, fingolimode)

Design outcomes

Primary

Measure	Time frame
1. Informed choice (Multi-dimensional Measure of Informed Choice (MMIC)) including the sub-dimensions risk knowledge, attitude and uptake. 2. Attitude towards immunotherapy will be assessed using a single question directly after the final physician encounter, i.e. up to 10 weeks after inclusion in the intervention group (IG) and up to 4 weeks after inclusion in the control group (CG). 3. Uptake of immunotherapy will be assessed from the patients 6 months after the final physician encounter (IG and CG) via a standardised telephone survey 4. Risk knowledge will be assessed using a previously developed and adapted questionnaire 14 days, 3 and 6 months after the last physician encounter (IG and CG). The cut off for adequate risk knowledge will be defined a priori as the value that 30% of all patients with highest scores reach at baseline. Informed choice is defined as adequate risk knowledge in combination with either uptake or non-uptake of immunotherapy and a corresponding (congruent) positive or negative attitude.	—

Measure

Time frame

1. Informed choice (Multi-dimensional Measure of Informed Choice (MMIC)) including the sub-dimensions risk knowledge, attitude and uptake. 2. Attitude towards immunotherapy will be assessed using a single question directly after the final physician encounter, i.e. up to 10 weeks after inclusion in the intervention group (IG) and up to 4 weeks after inclusion in the control group (CG). 3. Uptake of immunotherapy will be assessed from the patients 6 months after the final physician encounter (IG and CG) via a standardised telephone survey 4. Risk knowledge will be assessed using a previously developed and adapted questionnaire 14 days, 3 and 6 months after the last physician encounter (IG and CG). The cut off for adequate risk knowledge will be defined a priori as the value that 30% of all patients with highest scores reach at baseline. Informed choice is defined as adequate risk knowledge in combination with either uptake or non-uptake of immunotherapy and a corresponding (congruent) positive or negative attitude.

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Secondary

Measure	Time frame
1. Decisional Conflict Scale (DCS): The dyadic version of the DCS will be assessed as key secondary endpoint after the last coaching session (IG) and after the final physician encounter (IG and CG). 2. Control Preference Scale (CPS): Autonomy preference will be assessed using the CPS as web-based card set at baseline, 14 days as well as 6 months after the last physician encounter (IG and CG). 3. Planned Behaviour in MS (PBMS): Behavioural beliefs and self-efficacy concerning immunotherapy will be assessed using the PBMS questionnaire at baseline, 14 days as well as 6 months after the last physician encounter (IG and CG). 4. The Coping-Self-Efficacy-Scale (CSES): The questionnaire integrates a coping instrument and a self-efficacy measure, which will be assessed at baseline, 14 days as well as 6 months after the last physician encounter (IG and CG). 5. Duration of physician encounters will be estimated by patients (evaluation questionnaire) directly after the last physician encounter (IG and CG). 6. Decision adherence (including the decision against immunotherapy) and acceptance of the intervention will be assessed from patients using a standardised questionnaire 3 as well as 6 months after the last physician encounter (IG and CG). Assessment of safety: 1. Hospital Anxiety and Depression Scale (HADS): Anxiety and depression will be assessed at baseline, 14 days as well as 6 months after the last physician encounter (IG and CG). 2. Hamburg Quality of Life in MS Scale (HAQUAMS): Disease-specific quality of life will be assessed at baseline, 14 days as well as 6 months after the last physician encounter (IG and CG). 3. The Expanded-Disability-Status Scale (EDSS) will be assessed at baseline by a physician from the centre. 4. Relapses will be evaluated at baseline, 14 days as well as 3 and 6 months after the last physician encounter (IG and CG) using a standardised questionnaire.	—

Measure

Time frame

1. Decisional Conflict Scale (DCS): The dyadic version of the DCS will be assessed as key secondary endpoint after the last coaching session (IG) and after the final physician encounter (IG and CG). 2. Control Preference Scale (CPS): Autonomy preference will be assessed using the CPS as web-based card set at baseline, 14 days as well as 6 months after the last physician encounter (IG and CG). 3. Planned Behaviour in MS (PBMS): Behavioural beliefs and self-efficacy concerning immunotherapy will be assessed using the PBMS questionnaire at baseline, 14 days as well as 6 months after the last physician encounter (IG and CG). 4. The Coping-Self-Efficacy-Scale (CSES): The questionnaire integrates a coping instrument and a self-efficacy measure, which will be assessed at baseline, 14 days as well as 6 months after the last physician encounter (IG and CG). 5. Duration of physician encounters will be estimated by patients (evaluation questionnaire) directly after the last physician encounter (IG and CG). 6. Decision adherence (including the decision against immunotherapy) and acceptance of the intervention will be assessed from patients using a standardised questionnaire 3 as well as 6 months after the last physician encounter (IG and CG). Assessment of safety: 1. Hospital Anxiety and Depression Scale (HADS): Anxiety and depression will be assessed at baseline, 14 days as well as 6 months after the last physician encounter (IG and CG). 2. Hamburg Quality of Life in MS Scale (HAQUAMS): Disease-specific quality of life will be assessed at baseline, 14 days as well as 6 months after the last physician encounter (IG and CG). 3. The Expanded-Disability-Status Scale (EDSS) will be assessed at baseline by a physician from the centre. 4. Relapses will be evaluated at baseline, 14 days as well as 3 and 6 months after the last physician encounter (IG and CG) using a standardised questionnaire.

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 17, 2026