Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Strengths-based Intervention Based on Salutogenic Theory to Promote Sense of Coherence and Self-care of Elderly People With Type 2 Diabetes
1. Objectives of the Project
The BEYO project is designed based on the middle range theory of self-care of chronic
illness and salutogenic theory. The aim of this project is to facilitate self-care
behaviours of community-dwelling elderly patients with type 2 diabetes through promoting
SOC, and accordingly improve their health outcomes, including promoting quality of life
and reducing diabetes-related emotional distress.
2. Content of the Project
BEYO is a group-based consultation project. Each group contains 1 facilitator, 1 assistant
and 8 elderly patients. 5 weekly sessions are provided to let patients receive health
knowledge, discuss problems and experiences, explore available resources and build up goals
and solutions. Each session lasts for 40 minutes. Session 1 aims to build social network
among group members and introduce group goals and tasks. Session 2-4 covers six topics based
on the Chinese guideline for type 2 diabetes released by Chinese diabetes society: (i)
healthy dietary, (ii) exercise and activity, (iii) taking medication, (iv) blood glucose
monitoring, (v) reducing risks for complication, (vi) healthy coping with mental stress.
These middle sessions execute a common session flow to construct an action plan utilizing
patients' resources and strengths to achieve the client-centered goal. Session 5 aims to
review the process, summarize effective solutions, and set up plans for the future. One-week,
one-month and three-month telephone follow-ups are delivered to help patients solve problems
encountered during implementing the action plan and evaluate their self-care, SOC and other
health outcomes.
1. Overall aims The aim of this study is to develop and evaluate the effects of a
strengths-based group intervention called Be the Expert for Your Own (BEYO) among
elderly patients with type 2 diabetes to facilitate their SOC and self-care, and
accordingly improve their health outcomes.
2. Study Design This study is designed to be a mixed method research incorporating both
quantitative and qualitative components. A two-arm randomized controlled trial (RCT)
will be conducted to assess the effects of a strengths-based group intervention compared
with routine health education on SOC and self-care of elderly people with type 2
diabetes. The theoretical framework for BEYO program is based on salutogenic theory
proposed by Antonovsky (1987). Qualitative study will be conducted at the end of the
program to explore patients' experience about BEYO and the mechanism through which BEYO
can facilitate self-care, in terms of what component and how.
2. Be the Expert for Your Own (BEYO) program
1. Overview The BEYO protocol consists of 5 structured sessions among intervention
facilitator and 8 type 2 diabetes patients.The common flow for structured sessions
contains 7 steps. Rationale and aims for designing each step are described as follows.
Step 1 - "Health education" As supported by the middle range theory and results from
integrated review, knowledge acquisition is essential among patients with chronic
disease to perform reflective, sufficient and reasoned self-care actions with a pattern.
This step aims to equip patients with basic knowledge and essential skills to manage
their disease.
Step 2 - "Discuss self-care experience and identify deficit" This step aims to collect
basic information about clients' experience of performing self-care in each specific
area and identify major problems they encounter in this process. This step facilitates
information exchange and experience sharing among clients and provides reference for
intervention facilitator about clients' basic situation. Besides, giving enough
opportunity to describe the problem makes it easier to redirect the conversation later
if attendees restart talking about the problem.
Step 3 - "Describe exceptions" One of the central beliefs for SFT is that there are
always exceptions to problems. There are always times and situations when the problem
occurs less or when the client feels like successfully managing even a slight part of
the problem. After identifying self-care deficit, clients are asked to describe these
exceptional times in this step to help them find out skills, resources, and strengths at
their disposal. The close attention for exceptions improves clients' sense of
self-mastery and their ability to plan further steps.
Step 4 - "Identify the strengths" On the basis of review and analysis for exceptions, it
is the right time to list out and summarize clients' strengths revealed in these
exceptions. This step lays a foundation for establishing solutions later, for that
detected strengths can be amplified and repeated to ultimately dismantle the problem.
Step 5 - "Miracle question and scaling" The miracle question is a common tool in SFT as
a way to build clear, client-centered and practical goals. Scaling questions help to
break the goal down into small manageable steps that can be carried out in the short
term. This step helps clients find out what they want to achieve through this program.
Setting the goal by themselves facilitates an empowering and optimistic experience for
clients that promoting goal-focused thinking during the self-care process and
highlighting their responsibility for the future actions.
Step 6 - "Establish the solution" After exploring strengths and setting up the goal,
this step aims to link strengths and goals together to establish the solution. As the
basic principles for SFT is focusing on strengths rather than weakness, resources rather
than deficits, the created solution is more concerned with achievement than with solving
problems, with hoping not just coping. It helps clients move forward in their lives.
Step 7 - "Action plan" As the final step, a structured action plan is generated to
transform the solution into arranged tasks. The action plan guides the behaviors of the
clients and tracks the progress of implementation.
2. The role of facilitator Different with the traditional teacher-centered didactic model,
facilitators in BEYO program need to get out of the expert role and appreciate patients'
capabilities from the aspect of truly human beings. Rather than being at the center of
the group, the facilitator is a supporter to assist patients to identify what they want
to achieve, to help them to think about strengths and resources during the group
interactions, to build up solutions for their own situations and to make plans to reach
the goal step by step.
To build a hope-inducing relationship between the facilitator and clients has been
emphasized as the context for practice to enhance the effectiveness of strengths-based
techniques (Fischer, 1978). The foundation for a hope-inducing relationship includes
empathy, genuineness and unconditional positive regard (Maluccio, 1979). To be empathy,
facilitators need to perceive and communicate feelings of attendees with sensitivity,
and think about the meaning of these feelings. Genuineness means that facilitators
should be themselves in the helping process rather than presenting a professional
facade. Unconditional positive regard asks facilitators to give positive feedback to
every good change and to express the respect, acceptance, caring and concern for the
client in a non-dominating way.
3. Objectives for each session Session 1 aims to build social network among group members
and make clients feel welcome. Group goals and task will be introduced to gel the
clients around the group.
Session 2-4 execute a common session flow to finally construct an action plan to achieve
the client-centered goal. Themes for the total 3 sessions respectively cover the six
areas as mentioned earlier. Except session 2, all the other sessions will start with
reinforcing the positive change happening since the last session.
Session 5 aims to celebrate the achievement, review the process, summarize clients'
strengths and effective solutions, and set up plans for the future.
4. Acceptability and feasibility evaluation Researchers will record numbers and proportions
for recruitment, consent, attendance, and attrition rate. Duration of sessions and
intervention activities will be recorded using field notes. The research team and the
facilitator will discuss the delivery of the program and study progress every week.
The focus-group interview will be conducted at the end of the study to explore patients'
experience and opinions about the content and process, and barriers and enablers to
compliance with the intervention.
3. Subjects
3.1 Sampling and recruitment The group of elderly patients with type 2 diabetes living in
Changsha, a city in central China, is selected as the study population. Multi-stage random
sampling will be used to recruit community-dwelling participants. First, two of the five
municipal districts of Changsha City based on present administrative system will be randomly
selected. Second, detailed information including names and numbers of community health
service centers belong to each district can be achieved through government official websites.
Two community health service centers respectively belong to the two districts will be
randomly selected. Third, based on national standards of public health services, all the
community-dwelling patients with type 2 diabetes should be recorded in the electronic medical
system charged by the department of chronic disease management in the community health
service center. Random number table method will be used to select potential participants in
each of the two communities, using this electronic system. No private information of type 2
diabetes patients will be retrieved except for their name, mailing address and contact
number.
An information sheet will be sent as a letter from the research team to the potential
participant followed by a telephone call two days later. The phone call is mainly designed to
(i) further make sure if the referrals meet the inclusion criteria, such as age and time of
diagnosis; (ii) discuss the information sheet and obtain verbal informed consent for the
project, (iii) verbally deliver Abbreviated Mental Test (AMT) and the Summary of Diabetes
Self-Care Activities measure (SDSCA) to make sure the participants have intact cognitive
function and experience at least some degree of self-care deficit for diabetes.
3.2 Sample size calculation The significance level and the power are set at 5% and 80%
respectively. The primary outcome is self-care of elderly patients with type 2 diabetes.
However, based on the result of literature review, no previous studies used strengths-based
intervention reported its effects on self-care. Based on the result of a meta-analysis
assessing effects of group-based diabetes self-management education compared to routine
treatment (Steinsbekk, Rygg, Lisulo, Rise, & Fretheim, 2012), the standardized mean
difference for self-care skills was 0.55. Thus, a sample size of 53 in each group is enough
to detect the difference in the means of self-care between two groups. Allowing for a dropout
rate of 20%, a total of 132 participants will be required.
3.3 Randomization After obtaining the signed informed consent form and collecting the
baseline data, patients will be randomly allocated to the intervention or control group,
using a computerized permuted block randomization with concealment.
4. Data Collection Data collection will be commenced after receiving written informed consent
voluntarily signed by participants. The baseline information (T0) will be collected before
the randomization. After completing the intervention or control protocol, a follow-up data
collection (T1) will be conducted immediately by a group of trained research assistants, who
are blinded to the participants' group assignment and workshop attendance. Repeated data
collection (T2) will take place at 3 months after the completion of the strength-based
intervention by the same group of research assistants.
5. Data Analysis Plan Invalid questionnaire (questionnaire with obvious logic error, or with
more than 20% unanswered questions) will be excluded before put into the database. SPSS
version 22.0 will be used to process data. The level of statistical significance will be set
at 0.05. Q-Q plot, Skewness and Kurtosis will be used to examine the normality of continuous
data. Descriptive statistics will be used to summarize the demographic characteristics,
health status and patient-centered outcomes. The effectiveness of the intervention will be
assessed based on the intention-to-treat (ITT) principle. The generalized estimating equation
(GEE) model will be used to estimate the intervention effect over time. Hierarchical multiple
regression analysis will be conducted to examine the mediating effect of sense of coherence.
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