Clinical trial NCT02661165: How Does the Spirituality of Patients With Type 2 Diabetes Influence Their Self-management?
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?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: University of Southampton
First posted: 2016-01-22
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with T2D from a community or primary care clinic

Brief 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. 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.

Eligibility criteria: 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).

Primary outcomes:
measure: The self-management Interviews to identify if and how patients' spirituality influences their diet and exercise.
timeFrame: 58 months
Secondary outcomes:
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University of Southampton
state: Hampshire
Study officials:
affiliation: University of Southampton
name: Natasha Duke
role: PRINCIPAL_INVESTIGATOR
References: