Condition category
Not Applicable
Date applied
25/03/2011
Date assigned
28/04/2011
Last edited
13/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Susan Smith

ORCID ID

Contact details

Department of General Practice
Royal College of surgeons
Beaux Lane Huose
Mercer Street
Dubin
2
Ireland
+35(0)3 1402 2306
susansmith@rcsi.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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

Irish College of General Practitioners, Research Ethics Committee approved in December 2010

Study design

Prospective exploratory trial

Primary study design

Interventional

Secondary study design

Other

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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. James’s 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 client’s 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 trial start date

12/12/2010

Overall trial end date

30/08/2011

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

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

Trial participating centre

Department of General Practice,
Dubin
2
Ireland

Sponsor information

Organisation

HRB Centre for Primary Care Research (Ireland)

Sponsor details

Department of General Practice
Royal College of Surgeons
C/O Professor Susan Smith
Beaux Lane House
Mercer Street
Dublin
2
Ireland
+35 (0)3 1402 2306
susansmith@rcsi.ie

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23414187

Publication citations

  1. Results

    O'Toole L, Connolly D, Smith S, Impact of an occupation-based self-management programme on chronic disease management., Aust Occup Ther J, 2013, 60, 1, 30-38, doi: 10.1111/1440-1630.12008.

Additional files

Editorial Notes