Clinical trial NCT03950713: Mindfulness Program for Older-Diabetes
Official title: Taiwanese Mindfulness Program for Long Term Residents With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: Mindfulness-based Program
Relocation stress
Depression
Glycemic control
Lead sponsor: Fooyin University
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster randomized controlled trial was used to examine the effectiveness of the MBSR-T. The outcomes included HbA1c levels progression as the primary endpoint, and relocation stress, depression as secondary end points. Participants in the intervention group received the MBSR-T in addition to routine care. The control group received the routine care provided in facilities, including routine check-ups at diabetes clinics as necessary.
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the effectiveness of the newly developed Mindfulness-Based Stress Reduction-Taiwan program (MBSR-T) for old people with type 2 diabetes living in long-term care facilities.

Detailed description: This study reported the first randomized controlled trial of Mindfulness-based reduction stress for residents with type 2 diabetes newly moved into long-term care facilities on depression, relocation stress and HbA1c levels. The results highlighted the benefits of using strategies in the MBSR-T to promote good quality of diabetes care for residents in long-term care.

The contents of the 9-week MBSR-T program were adapted from an initial MBSR program by the Taiwan Mindfulness Association for older people with diabetes (Chinese version). The program consisted of a 1.5-hour session each week for 9-weeks for a group of 8 to 10 participants. Each session included 30 minutes of mindful deep breathing relaxation and 60 minutes of practicing mindfulness activities.

A total sample of 140 was determined. All eligible individuals in each long-term care facility were randomized by computerized random numbers, sequence generated by an independent statistician with one-to-one ratio for allocating to either control or intervention group. All participants were blinded to group allocation. Participants in the control group received usual care, while participants in the intervention group received the MBSR-T in addition to the usual care. All sessions in the MBSR-T were delivered by a trained mindfulness registered nurse who had received additional trainer qualification of mindfulness. A research assistant was blinded to the study protocol, who was employed to undertake data collection at baseline, at 3, 6, and 9 weeks (T0, T1, T2, T3).

Eligibility criteria: Inclusion Criteria:

* Age 65-85 years old
* Diagnosed with type 2 diabetes
* Moving into the facility within a year
* No obvious delirium, confusion or current psychiatric illness
* Being able to communicate in Chinese.

Exclusion Criteria:

* Terminally ill
* Unable to communicate in Chinese.

Primary outcomes:
measure: HbA1c values
timeFrame: Change from baseline HbA1c values at 12 weeks
Secondary outcomes:
measure: Relocation Stress Scale
timeFrame: Change from baseline relocation stress mean scores at 9 weeks
measure: Depression and Anxiety Stress Scale (DASS-21)
timeFrame: Change from baseline depression and anxiety stress mean scores at 9 weeks
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Fooyin University
Study officials:
affiliation: Fooyin University
name: Shu-Ming Chen
role: STUDY_CHAIR
References: