- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02661165
How Does the Spirituality of Patients With Type 2 Diabetes Influence Their Self-management?
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Hampshire
-
Southampton, Hampshire, United Kingdom
- University of Southampton
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
58 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Natasha Duke, University of Southampton
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- USouthampton
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes
-
Antonio Di MauroCompletedType-2 DiabetesItaly
-
DiaMedica Therapeutics IncCompletedDiabetes Type 2Netherlands
-
RenJi HospitalUnknownType 2 Diabetes.China
-
University of Erlangen-Nürnberg Medical SchoolCompletedType 2-diabetesGermany
-
Chengdu Brilliant Pharmaceutical Co., Ltd.Not yet recruitingType 2 Diabetes Mellitus
-
Nanjing First Hospital, Nanjing Medical UniversityRecruitingType 2 Diabetes MellitusChina
-
Xiangya Hospital of Central South UniversityRecruitingType 2 Diabetes MellitusChina
-
University of Alabama at BirminghamCompletedType 2 Diabetes MellitusUnited States
-
Imperial College LondonAstraZeneca; Huma; North West London Collaboration of CCGs (NWL CCGs); Imperial...CompletedType 2 Diabetes MellitusUnited Kingdom
-
Universiti Sains MalaysiaCompleted