Efficacy of client-centred occupational therapy in patients with multiple sclerosis: a cluster-randomized trial

Efficacy of client-centred occupational therapy in patients with multiple sclerosis: a cluster-randomized trial - Muscot

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30557

Enrollment

280

Registered

2007-03-01

Start date

2007-01-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

MS multiple sclerosis

Interventions

The experimental intervention comprises OT according to the OPPM. Clients treated by OT's from the experimental group will receive OT according to the OPPM. This means that problem identification, t

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Clients are eligible for inclusion if they have an existing diagnosis of MS; a new referral for OT with no previous OT treatment in the six months preceding inclusion; and age between 18 and 75.

Exclusion criteria

Exclusion criteria: Exclusion criteria are: major depression; refusal to provide informed consent; and insufficient control of the Dutch language.

Design outcomes

Primary

Measure	Time frame
The focus of the study is on the client, and primary and secondary outcomes are assessed at this level. The primary outcome measures are: - Disability Impact Profile (DIP). This questionnaire is commonly used to assess health-related quality of life in patients with MS and has adequate clinimetric properties. - Impact on Participation and Autonomy (IPA). This questionnaire was developed to assess the impact of chronic neurological diseases on outdoor and indoor autonomy, family role and social relations and also has adequate clinimetric properties.	—

Measure

Time frame

The focus of the study is on the client, and primary and secondary outcomes are assessed at this level. The primary outcome measures are: - Disability Impact Profile (DIP). This questionnaire is commonly used to assess health-related quality of life in patients with MS and has adequate clinimetric properties. - Impact on Participation and Autonomy (IPA). This questionnaire was developed to assess the impact of chronic neurological diseases on outdoor and indoor autonomy, family role and social relations and also has adequate clinimetric properties.

—

Secondary

Measure	Time frame
Secondary outcome measures at the client level include measures for the severity of MS (using the EDSS), client-centred therapeutic outcome (Canadian Occupational Performance Measure, COPM), dexterity (9-hole peg test, 9HPT), generic health-related quality of life (SF36), fatigue (MFIS), pain (PES) and cognitive functioning (PDQ). The quality of the client-therapist interaction as experienced by the client and the therapist will be assessed using the Quote-EEE questionnaire. Therapy compliance will be measured using a diary. Using this diary, the extent to which patients comply with therapeutic advice will be assessed. Additionally, no-shows, cancellation and rescheduling of therapeutic appointments will be inventoried. Additionally, an inventory of treatment goals is made, and the duration (in weeks) and intensity (number of therapeutic sessions, frequency of sessions) of OT are measured. At the level of the therapist, an inventory is made of the level of compliance with OPPM and attitude towards client-therapist interactions. Additionally, demographic information on the therapist will be collected. At the level of the institution, data will be collected on the organisation of care for MS patients, including any care received from other health care professionals (physiotherapists, clinicians, psychologists) within a multidisciplinary setting.	—

Measure

Time frame

Secondary outcome measures at the client level include measures for the severity of MS (using the EDSS), client-centred therapeutic outcome (Canadian Occupational Performance Measure, COPM), dexterity (9-hole peg test, 9HPT), generic health-related quality of life (SF36), fatigue (MFIS), pain (PES) and cognitive functioning (PDQ). The quality of the client-therapist interaction as experienced by the client and the therapist will be assessed using the Quote-EEE questionnaire. Therapy compliance will be measured using a diary. Using this diary, the extent to which patients comply with therapeutic advice will be assessed. Additionally, no-shows, cancellation and rescheduling of therapeutic appointments will be inventoried. Additionally, an inventory of treatment goals is made, and the duration (in weeks) and intensity (number of therapeutic sessions, frequency of sessions) of OT are measured. At the level of the therapist, an inventory is made of the level of compliance with OPPM and attitude towards client-therapist interactions. Additionally, demographic information on the therapist will be collected. At the level of the institution, data will be collected on the organisation of care for MS patients, including any care received from other health care professionals (physiotherapists, clinicians, psychologists) within a multidisciplinary setting.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)