Enhancing self-management of multimorbidity in primary care
| ISRCTN | ISRCTN67235963 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67235963 |
| Protocol serial number | N/A |
| Sponsor | HRB Centre for Primary Care Research |
| Funders | The Health Research Board Centre for Primary Care Research (Ireland), ref: HRC-1-2014, HRB Research Training Fellowship for Healthcare Professionals ref: HPF-2015-972 |
- Submission date
- 13/08/2013
- Registration date
- 30/08/2013
- Last edited
- 10/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
There is a high prevalence of multiple chronic conditions (also referred to as multimorbidity) in Irish general practices, which is associated with increased healthcare use and prescriptions. Issues that interfere with everyday activities and functioning for people with multimorbidity, include: (i) physical symptoms and their impact on function; (ii) psychological issues and (iii) impact on work and leisure activities. The physical symptoms include reduced mobility, physical limitations, pain and fatigue. Psychological issues include anxiety and feelings of inadequacy. With respect to work and leisure activities, multimorbidity interferes with social and leisure activities and job performance. This study investigates the effectiveness of OPTIMAL, an occupational therapy (OT) group-based intervention for individuals with multimorbidity.
Who can participate?
To take part in the study, participants must be over 40 years of age, have two or more chronic conditions and be on four or more repeat medications.
What does the study involve?
Participants are randomly allocated to a treatment group or to a waiting-list control group. The treatment group will receive the 6-week occupational therapy led self-management programme (OPTIMAL) and the control group will continue to receive care as usual and will be placed on a waiting list to receive the programme when the trial is complete. Topics covered in the self-management groups will include: activity and health, fatigue and energy management, managing stress and anxiety and maintaining mental health and well-being, keeping physically active, healthy eating, managing medications, communication skills and goal setting. All participants in the treatment group will receive the same programme.
What are the possible benefits and risks of participating?
Possible benefits of the 6-week programme include increased awareness of strategies for chronic disease management and increased ability to manage disease symptoms, and the groups will provide an opportunity to meet other individuals experiencing similar difficulties to gain insight into their self-management techniques. There are no risks of participating in the study.
Where is the study run from?
The study will be run across a number of local health or primary care centres in Dublin, Kildare and Wicklow. Participants will attend their local health centre for assessment and intervention.
When is the study starting and how long is it expected to run for?
Recruitment for the study will begin in February 2015 and the study will be completed in September 2018.
Who is funding the study?
This study is being funded by the Health Research Board (HRB) Research Training Fellowship for Healthcare Professionals and The Health Research Board Centre for Primary Care Research. The Health Research Board is the lead agency in Ireland supporting and funding health research.
Who is the main contact?
1. Ms. Lynn O' Toole
Email: otoolely@tcd.ie
2. Professor Susan Smith (scientific)
susansmith@rcsi.ie
Contact information
Scientific
Department of General Practice
Royal College of Surgeons
Beaux Lane House
Mercer Street
Dublin
2
Ireland
| Phone | +35 (0)3 1402 2306 |
|---|---|
| susansmith@rcsi.ie |
Public
Trinity College Dublin
Trinity Centre for Health Sciences
St. James Hospital
James Street
Dublin 8
D08 W9RT
Ireland
| Phone | +35 (0)3 864002582 /+35 (0)3 8963220 |
|---|---|
| otoolely@tcd.ie |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | 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 |
| Study acronym | OPTIMAL |
| Study objectives | An occupational therapy group-based chronic disease self-management intervention may improve outcomes for individuals with multimorbidity living in the community. Pilot study registered under ISRCTN70201320: http://www.isrctn.com/ISRCTN70201320 |
| Ethics approval(s) | 1. Exploratory study: Trinity College Dublin, Research Ethics Committee, 21/11/2012, ref: 21 November, 2012 2. Follow-up study: Trinity College Dublin, Faculty of Health Sciences Research Ethics Committee, 24/11/2015, ref: 150900 |
| Health condition(s) or problem(s) studied | Multimorbidity |
| Intervention | Participants in the intervention group will attend the OPTIMAL programme, a weekly chronic disease self management group facilitated by two primary care occupational therapists. Each session will last two and a half hours with a tea and coffee break in the middle. In total, three programmes will be run for the exploratory study (in three different primary care centres in Dublin - Ballyfermot, Rathmines and Thomas Street) and nine programmes will be run in different primary care centres in the follow-up study ( in Dublin, Kildare and Wicklow). Participants will attend the group in their local primary care centre to allow for ease of access. The content of the intervention is based on interventions delivered in the pilot study. The program content is based on chronic disease self management groups, and the priorities and difficulties experienced by people with multimorbidity as documented in literature. Each weekly session is divided into two halves, one which addresses an educational topic and the second half to address participants' individual goals. This group structure was chosen as self management programmes with the greatest impact are those which adopt a flexible approach to both delivery and content. The educational topics for the group sessions include: activity and health; fatigue management; healthy eating; maintaining physical activity (delivered by a community physiotherapist); maintaining mental health; managing medications (delivered by a pharmacist) and communicating effectively with health professionals. The format of this half of the session will include both group discussion and group activities. The second half of the session, individual goal setting, will involve the OTs and participants reviewing and setting identified goals, progress and addressing any barriers to goal achievement. All participants will complete a Canadian Occupational Performance Measure (COPM) as part of baseline assessment with intervention participants completing Goal Attainment Scaling. These are then used as the basis for the weekly goal setting in which individuals address personal goals in occupational performance and strategies to manage their conditions. The control group will continue to receive care as usual, and will act as a waiting-list control group. They will be offered the group sessions when the trial is complete if the programme is found to be effective. The intervention is of a 6-week duration. Primary outcome measures will be taken immediately post-intervention for both the intervention and the control group. Primary and secondary outcome measures will be taken 6- months post intervention for both the intervention and the control group. The control group will not receive the intervention but will complete follow-up at the same time as the control group. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Exploratory study: |
| Key secondary outcome measure(s) |
Exploratory study: |
| Completion date | 07/09/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Total final enrolment | 149 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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. |
| Date of first enrolment | 29/11/2012 |
| Date of final enrolment | 17/04/2017 |
Locations
Countries of recruitment
- Ireland
Study participating centres
2
Ireland
Trinity Centre for Health Sciences
St. James Hospital
James Street
Dublin 8
D08 W9RT
Ireland
Mercer Street Lower
Dublin
2
Ireland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/05/2015 | Yes | No | |
| Results article | Cost-effectiveness results | 05/02/2022 | 10/02/2022 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/02/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
05/09/2016: Internal review
09/03/2016: Changed condition category to unspecified
07/03/2016: Changed number of participants from 60 to 200. Changed funder details from "The Health Research Board" to "HRB Research Training Fellowship for Healthcare Professionals ref: HPF-2015-97 " and "The Health Research Board Centre for Primary Care Research (Ireland), ref: HRC-1-2014". Trial website link updated and participant information sheet link removed.
On 01/03/2016 there was a substantial update of this record in order to include details of a follow-up phase of the study. This included added extra information in the interventions, outcome measures, inclusion/exclusion criteria, study contact, overall and recruitment start and end dates, and ethics fields . No changes to the initial study details were requested.