The OPTIMAL study: A randomized controlled trial and process evaluation of an OccuPaTIonal therapy led self MAnagement support programme designed to improve occupational performance and outcomes for patients with muLtimorbidity in primary care

HRB Centre for Primary Care Research0 个研究点目标入组 149 人开始时间: 2013年8月30日最近更新: 2022年2月21日

试验速览

2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25962515 results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35137039/ Cost-effectiveness results (added 10/02/2022)

•Exploratory study:
•1. Over 18 years of age, both male and female
•2. Has a minimum of two chronic conditions
•3. Has a minimum of four repeat medication
•4. If a primary care clinician identifies they might benefit from the study
•Follow-up study:
•1. Multimorbidity, defined as two or more discrete conditions. This is the internationally accepted definition and encompasses a broad range of patients
•2. Age > 40 years. This limit was chosen as multimorbidity is relatively uncommon in patients younger than this and it facilitates targeted recruitment. There is no upper age limit
•3. Polypharmacy, defined as four or more repeat medications. This criterion was added in order to identify a group within the broader multimorbidity population that is at increased risk of poor health outcomes and therefore more likely to benefit from an intervention
•4. Ability to attend a local community healthcare centre to participate in data collection and the intervention groups

•Exploratory study:
•1. If unable to travel to centre in which groups were held
•2. If person had participated in the feasibility study (O'Toole, Connolly & Smith, 2013)
•Follow-up study:
•1. Psychiatric/psychological morbidity (such as psychosis) or cognitive impairment sufficient to impair participation in the intervention as confirmed by the individual’s GP and/ or practice nurse.
•2. Terminal illness likely to lead to death or major disability during the study follow-up period.
•3. Inability to attend intervention sessions held outside the home.
•4. Participated in the previous pilot studies or exploratory trial.

发起方

HRB Centre for Primary Care Research