Enhancing self-management of multiple conditions in primary care

ISRCTN	ISRCTN70201320
DOI	https://doi.org/10.1186/ISRCTN70201320
Secondary identifying numbers	N/A

Submission date: 25/03/2011
Registration date: 28/04/2011
Last edited: 13/11/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Not Applicable

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof Susan Smith
Scientific

Department of General Practice
Royal College of surgeons
Beaux Lane Huose
Mercer Street
Dubin
2
Ireland

Phone	+35(0)3 1402 2306
Email	susansmith@rcsi.ie

Study information

Study design	Prospective exploratory trial
Primary study design	Interventional
Secondary study design	Other
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A feasibility study of a chronic disease self-management intervention designed to improve occupational performance and outcomes for people with multimorbidity in primary care
Study acronym	Multimorbidity self-management
Study hypothesis	An occupational therapy group-based chronic disease self-management intervention may improve outcomes for individuals with multimorbidity living in the community.
Ethics approval(s)	Irish College of General Practitioners, Research Ethics Committee approved in December 2010
Condition	Multimorbidity
Intervention	Participants will attend a weekly chronic disease self management group (CDSM) over a six week period facilitated by the occupational therapy (OT) researcher. Each session will last two and a half hours with a tea and coffee break in the middle. The location selected for the group is Trinity Centre for Health Sciences, St. Jamess Hospital. This location has been chosen in an effort to minimise inconvenience to participants as it is easily accessible and has regular public transport and is the usual centre for specialist care for patients of the participating general practice. The content of the intervention is based on interventions delivered in the previous study (ICGP), program content of chronic disease self management groups, and the priorities and difficulties experienced by people with multimorbidity as documented in literature. Each session was divided into two halves one to address the educational topic and the second half to address participants individual goals. This group structure was chosen as self management programs with the greatest health impact are those with an individualised flexible approach to both delivery and content. Although generic self-management programs are effective they may not adequately address all of the concerns of complex patients with multimorbidity. Educational topics chosen for each group session are as follows: fatigue management, anxiety management, medicine management, physical activity, communication. The format of this half of the session will include both group discussions and group activities. This second half of the session, individual goal setting, will involve the OT researcher and participant reviewing and setting identified goals, progress and addressing any perceived barriers to goal achievement. All participants will complete a Canadian Occupational Performance Score (COPM) as part of baseline assessment, this can be used as the basis for the weekly goal setting in which individuals address personal goals in occupational performance that may not be addressed in educational topics.
Intervention type	Other
Primary outcome measure	1.The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure designed for use by occupational therapists to detect change in a client's self-perception of occupational performance over time. The COPM is a standardsed instrument administered in a semi-structured interview format at the beginning and end of OT intervention. Areas assessed using the COPM include the clients most important problems in occupational performance, perceptions of their performance in these activities and their level of satisfaction with their performance. 2. The Frenchay Activities Index (FAI) is a self report questionnaire designed to measure participation in social and instrumental activities of daily living. It measures how often the person has engaged in these activities (in the past 3 or 6 months depending on the nature of the activity). The measure contains 15 items divided into three sub scales (domestic chores, leisure work and outdoor activities) with five items in each. 3. The Nottingham Extended Activity of Daily Living Scale (NEADL) is a self-report scale measuring performance of activities of daily living, comprised of 22 items divided into four sections mobility, kitchen, domestic and leisure. Each item is given one of four responses (able, able with difficulty, able with help, unable) 4. Hospital Anxiety and Depression Scale is a reliable and valid self-assessment scale used to detect and indicate the severity of anxiety and depression in a hospital medical outpatient setting and was utilised in the previous research study. It consists of two subscales, anxiety (HADS-A) and depression (HADS-D) with seven items in each. 5. Stanford Chronic Disease Self-Efficacy Scale (6-item) measures study participants confidence levels in managing various elements of their chronic diseases such as exercise, social activities, household tasks, medication management and symptom management. 6. EQ-5D (Euroqol) is a valid and reliable self report questionnaire which measures current health related quality of life. The EQ-5D is a self report questionnaire for describing and valuing health-related quality of life (Aggarwal, 2009). It is a two-part measure consisting of a self-reported description (EQ-5D) and a self-rated valuation (EQ-VAS). The self reported description (EQ-5D) comprises five questions on mobility, self care, pain, usual activities, and anxiety/depression. The self rated valuation uses a vertical visual analogue scale (EQ-VAS) in which respondents rate their health today.
Secondary outcome measures	No secondary outcome measures
Overall study start date	12/12/2010
Overall study end date	30/08/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	30
Participant inclusion criteria	Patients aged over 18, with multimorbididty (defined as having two or more chronic conditions) and their general practitioner (GP) identifies that they may benefit from the study
Participant exclusion criteria	1. Patients will be excluded if they have a significant physical or mental illness which is likely to impair capacity to participate in the programme 2. Any patient currently participating in any other study will be excluded
Recruitment start date	12/12/2010
Recruitment end date	30/08/2011

Locations

Countries of recruitment

Ireland

Study participating centre

Department of General Practice,

Dubin
2
Ireland

Sponsor information

HRB Centre for Primary Care Research (Ireland)
University/education

Department of General Practice
Royal College of Surgeons
C/O Professor Susan Smith
Beaux Lane House
Mercer Street
Dublin
2
Ireland

Phone	+35 (0)3 1402 2306
Email	susansmith@rcsi.ie
"ROR"	https://ror.org/003hb2249

Funders

Funder type

Other

Investigator initiated and funded (Ireland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2013		Yes	No