Contact information
Type
Scientific
Primary contact
Prof David Whitford
ORCID ID
Contact details
RCSI-MUB
PO Box 15503
Adliya
Manamsa
15503
Bahrain
+973 17 58 35 00
dwhitford@rcsi-mub.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The null hypothesis is that implementation of a lengthened and multidisciplinary primary care consultation will have no impact upon the psychological health of mothers in terms of anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS).
Ethics approval
Approval received from the Research Ethics Committee of the Royal College of Surgeons in Ireland (RCSI REC) on the 13th December 2004 (ref: REC115).
Study design
This is a randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Condition
Depression of mothers in socially deprived area
Intervention
Families (with at least one child under the age of 16 years) with a history of social problems, substance misuse or depression will be identified by the general practices. Mothers of the families will be approached on behalf of the families and invited to participate in the research by letter and telephone follow up. Families agreeing to participate will be randomised into two equal sized non-stratified groups.
Intervention group:
A multidisciplinary lengthened primary care consultation will be given to the intervention families. The mothers and their families in the intervention group will be offered the multidisciplinary consultation with the Primary Health Care Team (PHCT) to assess their health and social needs. The General Practitioner (GP) will hold an initial discussion with the mother to discuss what her needs are, and this will guide the GP as to which members of the PHCT to invite to the trial consultation. The GP will invite up to other three members of the PHCT, who he or she feels will be able to give significant input, to help address the familys health and social problems. The health care professionals in attendance will actively participate in the consultation and offer advice and input where appropriate.
The GP will be in charge of running the consultation, and will have the whole PHCT from the Ballymun primary care project available to him or her. The GP will try to bring out all the health and social problems of the family so solutions may be worked out. Further lengthened consultations with the members of the primary care team may be required. The GP will arrange the appointments of the trial consultation for the families to attend. An allowance of up to an hour will be given for each case so that three consultations may be arranged per clinical session.
Control group:
The mothers and families in the control group will receive normal care from their GP and the PHCT.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The primary outcome of this study is the psychological health of mothers in terms of anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS), measured at 0, 6 months and 12 months.
Secondary outcome measures
1. Service delivery:
1.1. Frequency of GP and PHCT visits
1.2. Time spent with GP and PHCT
1.3. Referrals to secondary care and other agencies
2. Medical measures:
2.1. Health status (36-item Short Form health survey [SF-36])
2.2. Smoking status
2.3. Alcohol consumption
2.4. Substance misuse
3. Social measures:
3.1. School truanting
3.2. Unemployment
3.3. Family income
4. Psychological measures (psychotropic prescribing)
5. Satisfaction with management
It is not possible at the outset to determine whether an increase or decrease of service measures is beneficial. An assessment of the trend in referrals and time spent with primary care professionals will be made as the study comes to completion. All secondary outcomes will be measured at time 0, 6 months and 12 months.
Overall trial start date
07/02/2004
Overall trial end date
31/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Inclusion - must be mothers who:
1. Have at least one child under 16 years old
2. Have multiple physical or mental health and/or social and/or alcohol and/or drug problems
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
92 families
Participant exclusion criteria
1. Mothers of the families who are under 18 years of age
2. English is not the first language
3. Mothers who have a learning disability or dementia
4. Have high financial income, i.e., non-General Medical Services (GMS) (means tested access to medical services in Ireland)
Recruitment start date
07/02/2004
Recruitment end date
31/01/2007
Locations
Countries of recruitment
Ireland
Trial participating centre
RCSI-MUB
Manamsa
15503
Bahrain
Sponsor information
Organisation
Royal College of Surgeons in Ireland (RCSI) (Ireland)
Sponsor details
123 St Stephens Green
Dublin
2
Ireland
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Research Board (Ireland) (ref: PC/2003/11)
Alternative name(s)
HRB
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Ireland
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
Basic results (scientific)
Publication list
1. 2007 Protocol: http://www.ncbi.nlm.nih.gov/pubmed/17598899
2. 2011 Results: http://www.ncbi.nlm.nih.gov/pubmed/21261966
Publication citations
-
Results
Chan WS, Whitford DL, Conroy R, Gibney D, Hollywood B, A multidisciplinary primary care team consultation in a socio-economically deprived community: an exploratory randomised controlled trial., BMC Health Serv Res, 2011, 11, 15, doi: 10.1186/1472-6963-11-15.
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Whitford DL, Chan WS, A randomised controlled trial of a lengthened and multi-disciplinary consultation model in a socially deprived community: a study protocol., BMC Fam Pract, 2007, 8, 38, doi: 10.1186/1471-2296-8-38.