Type 2 DiabetesNCT02661165
How Does the Spirituality of Patients With Type 2 Diabetes Influence Their Self-management?
An observational study of Type 2 Diabetes, run by Natasha Duke at 1 site in United Kingdom.
Trial summary
This exploratory study is researching how the spirituality of a group of British patients with type 2 diabetes (T2D), impacts their approach to the self-management of their condition. Bio-statistical markers will be taken from consenting participants' Clinic database records. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2016to 26 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with T2D from a community or primary care clinic
Who may be able to join
- Speak English
- Have had T2D at least 6 months.
- Have read the Participant Information Sheet, explaining this study is regarding T2D, spirituality, coping and self-management.
- Gives consent to access their diabetes details that are stored on a Clinic database.
- Gives consent to recorded interviews.
Who cannot join
- Not speak English.
- Have had T2D less than 6 months.
- Have read the Participant Information Sheet, and decided they are not comfortable talking about their T2D, or spirituality, or coping or their self-management.
- Not consenting to data collection from Clinic records.
- Clinic records have not been kept (e.g. is a new patient to their family doctor).
- Consent is withdrawn from the study (which could be any stage).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study: How Does the Spirituality of a Group of British People With Type 2 Diabetes Impact Their Coping and Self-management of Their Condition?
This exploratory study is researching how the spirituality of a group of British patients with type 2 diabetes (T2D), impacts their approach to the self-management of their condition.
Bio-statistical markers will be taken from consenting participants' Clinic database records. Qualitative interviews will be conducted with participants, and the results analysed and interpreted, alongside their bio-statistical markers.
Results will be presented in healthcare peer reviewed journals and conferences, to inform clinicians how patients' self-management of their T2D is influenced by their spirituality.
Read the detailed description
Patients will be recruited from diabetes clinics.
The bio-statistical markers will be: include their living situation (living alone or with family/partner); date of T2D diagnosis; current age; glycated haemoglobin (hba1c) blood test; body mass index and current pharmacological therapy. This data will be collected from the Diabetes Clinic to contextualize the qualitative data. These measurements will reveal how well a participant is managing their T2D.
The Biographic Narrative Interpretive Method (BNIM) will involve interviews with eight participants. Each participant will have at least 2 and possibly 3 interviews at a location of their choice. The data will undergo thematic analysis, which will be interpreted.
The results will be used to encourage clinicians to consider the spirituality of people with T2D when planning their care, thus giving holistic treatment.
- Conditions
- Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
The self-management Interviews to identify if and how patients' spirituality influences their diet and exercise.
An exploratory study using qualitative data only to identify if and how patients' spirituality influences their diet and exercise, both of which are key to good diabetes control, and the prevention of diabetic complications in the long term. (No quantitative data will be collected, and as such no outcome measures will be collected).
Interviews will utilize the biographical narrative interpretive method to reveal how beliefs may influence diet and exercise. Each interview may last up to 3 hours. Each participant will be interviewed up to 3 times (approximately 9 hours of interviewing per participant). Interviews will be transcribed verbatim. Themes will be generated, coded and interpreted. Results will be the researchers interpretive analysis of the qualitative data generated, and the themes that emerge.
Measured: 58 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startJun 2016
- Primary completion26 Apr 2018
- Study completion26 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natasha Duke
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton
- Responsible party
- Sponsor-investigator, Natasha Duke, University of Southampton
- Investigators
- Natasha Duke, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661165
- Sponsor's protocol ID
- USouthampton
- Status last verified
- Jun 2020
- First submitted
- 17 Dec 2015
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study: How Does the Spirituality of a Group of British People With Type 2 Diabetes Impact Their Coping and Self-management of Their Condition?
- ClinicalTrials.gov ID
- NCT02661165
- Acronym / sponsor ID
- USouthampton
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Natasha DukeUniversity, hospital or other
- Collaborators
- University of Southampton
- Study start
- Jun 2016
- Primary completion
- 26 Apr 2018 (actual)
- Study completion
- 26 Apr 2018 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This exploratory study is researching how the spirituality of a group of British patients with type 2 diabetes (T2D), impacts their approach to the self-management of their condition.
Bio-statistical markers will be taken from consenting participants' Clinic database records. Qualitative interviews will be conducted with participants, and the results analysed and interpreted, alongside their bio-statistical markers.
Results will be presented in healthcare peer reviewed journals and conferences, to inform clinicians how patients' self-management of their T2D is influenced by their spirituality.
Detailed description
Patients will be recruited from diabetes clinics.
The bio-statistical markers will be: include their living situation (living alone or with family/partner); date of T2D diagnosis; current age; glycated haemoglobin (hba1c) blood test; body mass index and current pharmacological therapy. This data will be collected from the Diabetes Clinic to contextualize the qualitative data. These measurements will reveal how well a participant is managing their T2D.
The Biographic Narrative Interpretive Method (BNIM) will involve interviews with eight participants. Each participant will have at least 2 and possibly 3 interviews at a location of their choice. The data will undergo thematic analysis, which will be interpreted.
The results will be used to encourage clinicians to consider the spirituality of people with T2D when planning their care, thus giving holistic treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with T2D from a community or primary care clinic
Key inclusion criteria (5 listed)
- Speak English
- Have had T2D at least 6 months.
- Have read the Participant Information Sheet, explaining this study is regarding T2D, spirituality, coping and self-management.
- Gives consent to access their diabetes details that are stored on a Clinic database.
- Gives consent to recorded interviews.
Key exclusion criteria (6 listed)
- Not speak English.
- Have had T2D less than 6 months.
- Have read the Participant Information Sheet, and decided they are not comfortable talking about their T2D, or spirituality, or coping or their self-management.
- Not consenting to data collection from Clinic records.
- Clinic records have not been kept (e.g. is a new patient to their family doctor).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The self-management Interviews to identify if and how patients' spirituality influences their diet and exercise.
Time frame: 58 months
An exploratory study using qualitative data only to identify if and how patients' spirituality influences their diet and exercise, both of which are key to good diabetes control, and the prevention of diabetic complications in the long term. (No quantitative data will be collected, and as such no outcome measures will be collected). Interviews will utilize the biographical narrative interpretive method to reveal how beliefs may influence diet and exercise. Each interview may last up to 3 hours. Each participant will be interviewed up to 3 times (approximately 9 hours of interviewing per participant). Interviews will be transcribed verbatim. Themes will be generated, coded and interpreted. Results will be the researchers interpretive analysis of the qualitative data generated, and the themes that emerge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natasha Duke principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Natasha Duke at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The self-management Interviews to identify if and how patients' spirituality influences their diet and exercise. (time frame: 58 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.