A research study in Uganda to test the acceptability and feasibility of an intervention called DIALOG+, designed to improve care for people in primary care with poor physical and mental health
| ISRCTN | ISRCTN50335796 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50335796 |
| Secondary identifying numbers | 16/137/97 |
- Submission date
- 27/11/2020
- Registration date
- 02/12/2020
- Last edited
- 16/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
DIALOG+ is an intervention delivered on a tablet or smartphone using an app. It is designed to help mental health professionals to improve the structure of their routine meetings with patients. It also helps to improve communication with patients during these meetings. Patients are first asked about how satisfied they are with eight areas of their lives (e.g. physical health, family relationships, leisure activities) and three areas of the treatment they are receiving (e.g. practical help, meetings), which is called the DIALOG scale. The patient then chooses up to three areas to discuss in more depth with their health professional. The clinician then discusses each area chosen by patients, using four steps that focus on solutions to the identified problems. This study aims to find out whether DIALOG+ can be adapted to be used to improve care for people in primary care with physical conditions and poor quality of life in Uganda. More specifically, the researchers want to find out how patients and health professionals experience DIALOG+ when it is used during their routine meetings. They also want to find out if DIALOG+ improves outcomes like quality of life and other symptoms in order to plan for larger definitive trials if indicated.
Who can participate?
Adults in primary care who have at least one common noncommunicable chronic condition (such as diabetes, hypertension, chronic obstructive pulmonary disease, cardiovascular disease, etc) and who have a low quality of life
What does the study involve?
The initial stage of this study involves a suggested adaptation of DIALOG+ from other trials that have been conducted. Potential minor adaptations may include suggested modifications to the number of domains addressed, item wording and training examples. DIALOG+ will be adapted to primary care settings to enable wider use with patients with chronic physical and mental health conditions with assessments before and 3 months after the intervention. The adaptation process will be through stakeholder consultation based on actual experience of using the intervention. The results will provide insight into refining the training process and implementing the intervention across healthcare settings.
What are the possible benefits and risks of participating?
DIALOG+ is a resource-oriented and evidence-based intervention which makes use of existing personal and social resources to improve the quality of life of patients with mental illness. The intervention is low cost using routine meetings between patients and clinicians without the need for additional referrals or services. The researchers will adapt DIALOG+ for primary care to improve reach and enable a larger patient population to benefit. Additionally, the study focuses on a new and vulnerable population – those with comorbid (simultaneously present) non-communicable chronic physical and mental health problems. Research has shown that comorbid physical and mental health problems are common, resource-intensive and result in a poor quality of life for billions of people worldwide.
A potential benefit for all participants involved in the study is that their suggestions and experiences might be incorporated into further adaptations, which will tailor the intervention to the needs of patients and clinicians in the context of the primary care system in Uganda. Additionally, for patients who will be involved in testing the DIALOG+, this might lead to improved quality of life, social functioning, and symptoms. The study will also benefit clinicians involved in terms of the training they will receive. Clinicians involved in the DIALOG+ study will be provided with training and supervision to enable them to implement the intervention.
The researchers do not foresee any significant ethical, legal or management issues arising from this study. Within the assessments and interviews that will take place across both studies, questions will be raised with participants that might trigger feelings of distress or anxiety. Participants may experience anxiety in trying new interventions. Throughout the intervention-testing period, participants will continue to receive their routine care, including any medication, in addition to the intervention. The intervention can be stopped at any point. The use of DIALOG+ in mental health care settings has an evidence base for effectiveness and the researchers believe this is easily transferable across to physical health care too without any additional risks. To minimise the impact of potential risks, risk management strategies have been outlined in the study protocol.
Where is the study run from?
Outpatient clinic at Mityana and Masaka Hospitals (Uganda)
When is the study starting and how long is it expected to run for?
November 2019 to June 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Francois van Loggerenberg, f.vanloggerenberg@qmul.ac.uk
Contact information
Scientific
Unit for Social and Community Psychiatry
Queen Mary University of London
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
 ORCID ID |
0000-0001-5317-7983 |
|---|---|
| Phone | +44 (0)207 540 4380 Ext: 2339 |
| f.vanloggerenberg@qmul.ac.uk |
Public
Unit for Social and Community Psychiatry
Queen Mary University of London
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
| ORCID ID |
0000-0001-5317-7983 |
|---|---|
| Phone | +44 (0)207 540 4380 Ext: 2339 |
| f.vanloggerenberg@qmul.ac.uk |
Study information
| Study design | Non-randomized design using mixed methods and before and after assessments |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Testing the acceptability and feasibility of DIALOG+ in patients with common chronic conditions and poor mental health in primary care in Uganda: a non-randomized study with before and after design |
| Study hypothesis | The study aims to test the feasibility and acceptability of and adapted DIALOG+ intervention for patients with comorbid physical and mental health conditions in primary care. The main research questions are: 1. Is the use of DIALOG+ feasible and acceptable in primary care for patients with non-communicable physical health conditions 2. How do we adapt the DIALOG+ intervention through a process of stakeholder consultation and use the adapted version to refine training materials? 3. How does the adapted DIALOG+ intervention affect patient outcomes? |
| Ethics approval(s) | 1. Approved 05/11/2020, Makerere University, College of Health Sciences School of Medicine Research and Ethics Committee (PO Box 7072 Kampala; +256 (0)414 533541; research@chs.mak.ac.ug), ref: 2020-195 2. Approved 18/12/2020, Uganda National Council of Science and Technology (PO Box 6884, Kampala; +256(0)41 4705500), ref: HS1116ES 3. Approved 27/01/2021, Queen Mary Ethics of Research Committee (Hazel Covill, Room W117, Finance Department, Queens’ Building, Queen Mary University of London, Mile End Road, London, E1 4NS, UK; +44 (0)20 7882 7915; h.covill@qmul.ac.uk), ref: QMERC20.101 |
| Condition | Chronic conditions such as diabetes, hypertension, chronic obstructive pulmonary disease (COPD), cardiovascular disease (CVD) |
| Intervention | DIALOG+ is a technology-mediated intervention, which involves a structured patient assessment covering satisfaction with eight life domains and three treatment domains (DIALOG scale) and a four-step solution-focused therapy approach to address patient concerns (DIALOG+). DIALOG+ aims to make routine meetings between clinicians and patients therapeutically effective. Once enrolled, patients will receive DIALOG+ at their routine primary care appointments, around once per month. This will be delivered by the healthcare worker using an app on a tablet computer. The intervention period will be 3 months, during which patients will attend up to three DIALOG+ sessions. Data collection with all participants will take place at baseline and following the 3-month intervention period. At baseline, the researchers will collect socio-demographic information from all participants, which, for patient participants, will include clinical characteristics. A subset of participants will be invited to attend a qualitative interview after the end of the intervention (3 months) in order to capture the individual experience of the intervention; including barriers and facilitators of attending intervention sessions, suggested adaptations and the practical delivery of the intervention. In addition to the research data collection, the research and clinical support staff keep a record of their intervention sessions. These reports will include the date, duration of interventions and the topic of discussion. This information is also captured within the DIALOG+ app and can be retrieved by the research staff. The aim is to record at least one session per patient, which will be scored for adherence. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Quality of life measured using the Manchester Short Assessment (MANSA) at baseline and 3 months 2. Depression measured using the Patient Health Questionnaire (PHQ-9) at baseline and 3 months 3. Anxiety measured using Generalised Anxiety Disorder assessment (GAD-7) at baseline and 3 months 4. Objective social functioning measured using objective social outcomes index (SIX) at baseline and 3 months 5. Physical health symptoms measured using The Short Form (36) Health Survey (SF-36) at baseline and 3 months |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 07/11/2019 |
| Overall study end date | 25/06/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Approximately 10 clinicians with around 6 patients each, for a total of 60 patient participants |
| Total final enrolment | 182 |
| Participant inclusion criteria | 1. Diagnosis of ≥1 common chronic non-communicable condition such as diabetes, hypertension, COPD, CVD, etc 2. Quality of life score measured on the MANSA ≤5 3. Capacity to provide informed consent assessed using the UBACC 4. Able to speak and understand the local language 5. Attending the outpatient clinic for at least 6 months 6. Live within a 20 km radius of the clinic 7. Aged 18 years and above |
| Participant exclusion criteria | 1. Unable or unwilling to provide informed consent 2. Does not meet inclusion criteria |
| Recruitment start date | 15/02/2021 |
| Recruitment end date | 07/04/2021 |
Locations
Countries of recruitment
- Uganda
Study participating centres
Mityana
Uganda
Uganda
Masaka
Uganda
Uganda
Sponsor information
University/education
Mile End Road
London
E1 4NS
England
United Kingdom
| Phone | +44 (0)20 7882 5555 |
|---|---|
| jrmo-helpdesk-smdpostaward@qmul.ac.uk | |
| Website | http://www.qmul.ac.uk/ |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers intend to publish the quantitative and qualitative findings from this study by July 2022. Regarding dissemination, this study is part of a research group which also aims to build sustainable research capacity. The dissemination plan therefore aims to inform research, policy and practice. The researchers plan to disseminate findings across Uganda, and regionally. Dissemination will include publications, attending conferences, and using platforms like Twitter and the group website. |
| IPD sharing plan | The datasets will be held at QMUL in anonymised form. Data sharing with external interests will be considered only after the publication of the findings that reflect the given data. The datasets will be available upon request from Stefan Priebe (s.priebe@qmul.ac.uk). The data collected will be both quantitative and qualitative. The duration of availability of data has not yet been decided. During the course of the study, data will be shared internally between the research group using an online data collection platform called REDCap. The method for sharing the data externally (if required) will be decided in due course. Informed consent will be obtained from all participants involved in the study. All participants are assigned a patient ID at the point of enrolment and all subsequent data collected will be linked to this ID, without any link to identifiable data following Good Clinical Practice. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 30/09/2021 | 04/10/2021 | Yes | No | |
| Results article | 16/11/2023 | 16/11/2023 | Yes | No |
Editorial Notes
16/11/2023: Publication reference added.
03/03/2023: The intention to publish date was changed from 31/03/2023 to 31/07/2023.
07/12/2022: The intention to publish date was changed from 31/12/2022 to 31/03/2023.
06/12/2022: A contact was removed.
08/06/2022: The intention to publish date has been changed from 30/06/2022 to 31/12/2022.
01/03/2022: The intention to publish date has been changed from 31/03/2022 to 30/06/2022.
13/12/2021: The intention to publish date was changed from 31/12/2021 to 31/03/2022.
04/10/2021: The following changes have been made:
1. Publication reference added.
2. The public and scientific contacts have been changed and the plain English summary updated accordingly.
12/07/2021: The following changes were made to the trial record:
1. The overall trial end date was changed from 29/06/2020 to 25/06/2021.
2. The intention to publish date was changed from 01/10/2021 to 31/12/2021.
07/07/2021: The following changes have been made:
1. The total final enrolment number has been changed from 60 to 182.
2. The overall trial end date has been changed from 01/07/2021 to 29/06/2020 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 31/07/2022 to 01/10/2021.
15/06/2021: The following changes have been made:
1. The recruitment end date has been changed from 01/06/2021 to 07/04/2021.
2. The overall trial end date has been changed from 31/07/2021 to 01/07/2021.
3. The total final enrolment number has been added.
19/02/2021: The Queen Mary Ethics of Research Committee and Uganda National Council of Science and Technology ethics approval references have been added.
18/02/2021: The recruitment start date was changed from 01/01/2021 to 15/02/2021.
01/02/2021: The recruitment end date was changed from 15/02/2021 to 01/06/2021.
27/01/2021: The ethics approval was added.
08/01/2021: The recruitment start date was changed from 01/01/2021 to 15/02/2021.
30/11/2020: Trial's existence confirmed by Makerere University, College of Health Sciences School of Medicine Research and Ethics Committee.
