Mindfulness Program for Older-Diabetes

Sponsor
Fooyin University (Other)
Overall Status
Completed
CT.gov ID
NCT03950713
Collaborator
(none)
140
1
2
6.9
20.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T)
N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Taiwanese Mindfulness Program for Long Term Residents With Type 2 Diabetes
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Jul 31, 2017
Actual Study Completion Date :
Jul 31, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T)

Participants in the intervention group received the MBSR-T in addition to routine care.

Behavioral: Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T)
The MBSR-T is focused on strategies to manage diabetes distress for new residents by three new techniques. Firstly, it involves practicing body and meditation exercises for openness to the awareness and acceptance of transferred life experiences, such as mindful attention exercise, which is assumed to allow the residents to behave in a less reactive and more reflective manner when confronted with transferred life stressors. Second, mindfulness meditation techniques were provided for difficult thoughts and feelings related to diabetes, such as paying full attention to the present moment of life and choosing to respond skillfully rather than reacting automatically to external events, thoughts or emotions as they arise. Third, a specific topic, for example on how to be mindful when life style is changed, or how to pay attention to the present moment within Chinese culture of peacefulness was discussed in each session.

No Intervention: Routine care

The control group received the routine care provided in facilities, including routine check-ups at diabetes clinics as necessary.

Outcome Measures

Primary Outcome Measures

  1. HbA1c values [Change from baseline HbA1c values at 12 weeks]

    Glycemic control was measured by HbA1c values, and data were collected from participants' medical records.

Secondary Outcome Measures

  1. Relocation Stress Scale [Change from baseline relocation stress mean scores at 9 weeks]

    Relocation Stress Scale (Chinese version), This scale is a 29-item functional assessment of health status with a 5-point Likert scale (5 is the highest relocation stress, 1 is the lowest). The internal consistency .72 has been reported.

  2. Depression and Anxiety Stress Scale (DASS-21) [Change from baseline depression and anxiety stress mean scores at 9 weeks]

    The Depression and Anxiety Stress Scale (DASS-21) was used to measure depression. The DASS-21 in Chinese version consists of 21 items with a 4-point Likert scale. The good internal consistency for the DASS-21 subscales .92 for depression, .94 for anxiety, and .91 for stress have been reported.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fooyin University Kaohsiung City Taiwan 83102

Sponsors and Collaborators

  • Fooyin University

Investigators

  • Study Chair: Shu-Ming Chen, Fooyin University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fooyin University
ClinicalTrials.gov Identifier:
NCT03950713
Other Study ID Numbers:
  • FYH-IRB-1040602
First Posted:
May 15, 2019
Last Update Posted:
May 15, 2019
Last Verified:
Aug 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fooyin University

Study Results

No Results Posted as of May 15, 2019