Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03055468 |
| Other study ID # |
MakerereU |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
February 9, 2017 |
| Last updated |
March 10, 2017 |
| Start date |
April 1, 2017 |
| Est. completion date |
March 30, 2018 |
Study information
| Verified date |
March 2017 |
| Source |
Makerere University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Introduction: The prevalence of Diabetes Mellitus (DM) is on the rise the world over. About
30% of DM patients suffer from Depression. Depression in DM patients is associated with
adverse outcomes including poor medication adherence, poor glycaemic control, and early
death. In resource constrained sub-Saharan Africa (SSA) clinics where patient volumes are
high and staff shortages rife, peer support has been suggested as a means of delivering
psychosocial care for persons with chronic illnesses in order to improve patient's outcomes.
However, little has been done to examine the efficacy of peer support on clinical outcomes.
Project aims: The main study objective will be developing a peer support model of depression
care for patients with DM and testing its efficacy on clinical outcomes.
Methods: This study will employ both qualitative and quantitative measures. First, the
investigators will present the peer support model to health workers within the DM clinic,
and ask them about the feasibility of using such a model for DM patients with depression.
The investigators will then identify 10 DM patients with major depression and initiate them
on antidepressants. Once the patients are in clinical remission, the investigators will
interview them to assess their perceptions about the feasibility of using peer support for
DM patients newly diagnosed with depression. The investigators will also interview health
care workers and hospital administrators to assess their perception about using peer support
within the clinics, and potential barriers that need to be addressed before implementation
of the model.
Based on the data from the qualitative interviews, the investigators will refine and adapt
the peer support model, and then train 10 DM patients who have received antidepressants and
are in clinical remission to deliver peer support to newly diagnosed patients with
depression. Newly diagnosed depressed patients will be randomly assigned to receive either
antidepressants plus peer support (n=65) or antidepressants alone (n=65). Study participants
will be followed for 48 weeks and assessed for, glycaemic control, depression severity,
mental illness stigma, depression treatment uptake and adherence.
Result: the investigators anticipate that the findings about the efficacy of peer support on
DM and depression outcomes will be useful in generating data about effect sizes necessary
for calculating a sample size for a cluster randomized trial (CRT).
Description:
Methods: This will be a pragmatic randomized control trial with a 1:1 allocation ratio
between cases and controls.
Study Setting: This project will be implemented at the DM clinic of Nsambya Hospital in
Kampala City. The clinic, which is staffed by three nurses, a medical officer and a
specialist physician, is open once a week. The nurses provide most of the DM care including
eliciting symptoms, providing medication refills, as well as referring complicated cases to
the medical officer (MO) and specialist physician. The medical officer and specialist
physician manage referrals and complications of DM.
Identification of depressed patients to participate in a peer support feasibility study: In
the first four weeks of the study, all clinic attendees will be screened for depression by a
trained lay health care worker(TLHW) using the PHQ-2 at triage. Screen positive cases
(PHQ-2≥3) will be sent to the MO who will conduct a depression diagnostic interview using
the Mini International Neuropsychiatric Interview (MINI) till 10 depressed patients are
identified. All depressed patients will be initiated on either Imipramine 75mg/day or
Fluoxetine 20mg/day, and then reassessed at week 4 and week 6 for side effects and symptom
remission using the Hamilton Depression Rating scale (HAM-D).
Conducting qualitative interviews to assess feasibility of peer support: When the 10
patients are in remission (˜ 6-8 weeks) the investigators will conduct qualitative
interviews with them, hospital administrators (n=2), and medical personel at the DM clinic
(n=5). During the interview, the investigators will assess the participant's perceptions
about the feasibility and acceptability of engaging experienced DM patients to provide peer
support to patients newly diagnosed with depression. Informed consent will be sought from
all participants.
Interview procedure: Dr Elialilia Okello will conduct the qualitative interviews. The
participants will be asked about whom in the DM clinic would be a suitable candidate to
provide peer support to newly diagnosed depressed patients. The peer support model will be
presented to participants so that they can internalize/appreciate the concept, Interview
guide: The interviews will be based on a guide with detailed standard probes to ensure that
key questions are addressed, and to allow comparisons across individuals and categories of
respondents. Questions will be open-ended to allow not only the exploration of new leads but
also generation of rich narratives. All interviews will be tape recorded, translated in
English (in cases where Luganda, the local language is used) and transcribed verbatim.
Qualitative data analysis: Data will be explored to identify key themes and relationships
between themes and analyzed using Atlas.ti. The results from the qualitative interviews will
help the investigators refine the peer support model before using it.
After the depressed patients are in full clinical remission, the investigators will ask
clinic staff to nominate from among them atleast 5 potential candidates to become peer
support buddies. This number should be adequate for the investigators to pilot test atleast
5 interview groups for the peer support process. Self-nominations will also be encouraged
after the patients on treatment are made aware of the eligibility criteria. The eligibility
criteria will be patients who are; (a) at least 18 years of age; (b) speak Luganda; (c)
registered at the clinic for at least 6 months; (d) successful adherer, defined by staff as
one who consistently keeps appointments and self-reports being able to adhere to treatment;
(e) not currently suffering from any physical or co-morbid mental illness, or using
substances of abuse ; (f) socially skilled as defined (albeit subjectively) by staff; (g),
and have received antidepressants for at least 10 weeks (and in clinical remission for at
least 4 weeks). The investigators will screen more clinic attendees to identify potential
buddies if the number identified using the method above is less than 5. Patients who are
depressed and are ineligible to become peer support buddies will be followed up for the
duration of the study as controls.
Buddy training: A 2-day training workshop of the peer support "buddies" will be conducted by
the PI using the buddy training manual developed by Simoni. The workshop will include
didactic content, and role-plays. Buddies will be taught strategies geared to address the
four components of peer support (self-care, adherence, stigma, and social support). Buddies
will meet in a group for supervision with the PI to seek for clarity in areas that were
missed out earlier before they can be assigned newly diagnosed patients. Once trained, the
buddies will be assigned no more than 5 patient peers at any one time.
Content of peer support training: Buddies will be taught to strive toward the following
goals with their assigned peers: (a) explain the purpose of the contacts as educational and
supportive, aimed at helping the peer to adhere to both antidepressants and hypoglycaemic
medications; (b) learn the peer's regimen and make suggestions on how to follow it,
borrowing from their own experiences; (c) encourage peers to follow treatment regimens by
praising them for adherence and by expressing confidence in their ability to adhere; (d)
allow the peer to express worry, anxiety, and concerns so these can be dealt with, (e) be
warm and friendly, (f) and refer frequently to themselves and their success with their own
regimen to present a guide or model which the peer can follow. The peers and buddies will
use the above goals to set achievable targets for each meeting. Buddies will be specifically
instructed not to give any medical advice to the peers, but rather encourage the peers to
discuss with their clinicians any questions of a medical nature.
Sample size and power calculation for the peer support study objective: The sample size for
the RCT component of the study was calculated to compare the primary outcomes as measured by
HbA1c ≤ 7 and HAM-D ≤7 between the intervention and control arms at 48 weeks after
initiation of antidepressant treatment. To calculate our sample size, the investigators used
findings from an RCT by Safren et al,[61]. Using the standard deviations of the means from
this study [61], the investigators estimated that 65 patients per arm (intervention vs.
control) are required to have 80% chance to detect, as significant at the 5% level, a 1.4
[SD = 2] mean difference in the HbA1c levels and HAM-D depression scores, taking into
account a 20% loss to follow-up at 48 weeks.
Peer support process: Participants in the intervention arm will receive peer support every
two weeks for 12 weeks, then monthly 'booster' sessions at weeks 16, 20, 24 and 28 after
commencing treatment. However, the results from our qualitative interviews will guide the
investigators about the feasibility of the number of meetings.
Peer support will be provided to a group of patients rather than a one-to one session. A
number of barriers (transport availability, distance from the clinic, work schedules) may
make it difficult to pre-determine when the meetings will take place, but the investigators
will ensure that the inclusion criteria for peers into the program includes their
willingness to attend all sessions. Buddies will keep ongoing records of all their contacts
with their peer clients as an assessment of the integrity of the intervention across
buddies, across peers, and over time.
Monitoring fidelity and supervision: In the first 4 weeks of implementation of the peer
support intervention (17 weeks into the study), all sessions will be audio recorded to
assess adherence to manual guidelines. The PI will then listen to the recordings, and then
advise the buddies accordingly. The peers will complete an anonymous evaluation
questionnaire following the first two sessions; information from these questionnaires will
be used to improve the quality of peer support. A buddy log will be designed to capture the
following information; a) which days the meetings occurred, b) duration of the meeting, c)
members present, d) issues discussed, and e) any challenges encountered. The investigators
will have a master's degree clinical psychologist sit in these meetings and also collect
this data from each of the buddies at the end of the meeting, and relay this data to the PI.
Over the entire duration of the intervention, the PI will also attend the sessions on a
rotator basis; the PI will have the chance of attending sessions from each of the groups.
The study participants from both arms will be followed up for 48 weeks after initiation on
antidepressant treatment. The patients in both arms will be reviewed by the MO at weeks 2
and 4 to address any challenges due to side effects, which are critical in preventing early
discontinuation of treatment. At each visit, the research assistant will use the HAM-D to
assess depression symptom severity, and the standardized side effect screening instrument
the antidepressant side effect check-list (ASEC) [63] to assess tolerance to medications and
any side effects. The HbA1c test will be performed at baseline, week 24 and 48. At these
visits, the research assistant will also collect data from the participants. Research data
will be collected at baseline, then weeks 12, 24, and 48 after initiation of patients into
treatment.
Quantitative data analysis: A trial profile shall be used to detail recruitment and
follow-up of patients. Analyses will be conducted to compare the groups at baseline, weeks
12, 24, and 48 to assess short- and long-term effects of the peer support intervention. The
investigators shall analyze the data using the intention-to-treat approach. The dependent
variables (HbA1c and HAM-D) will be presented as continuous variables. Predictor outcomes
including adherence, mental illness stigma levels, social support and self-care will be
presented as continuous and categorical variables. Baseline characteristics of the
intervention and control arms will be compared at the 5% level to assess if successful
randomization was achieved. Students t-tests (if continuous and normally distributed),
Mann-Whitney U-test (if continuous but non-normally distributed), and Chi-squared tests
(categorical) will be used. Data on potential confounders and effect modifiers, including
variables that fail to achieve successful randomization (e.g. sociodemographic parameters)
shall be used to control for confounding and effect modification. The investigators shall
conduct both within-subjects (time) and between-subject (group) analyses. Between-subject
analysis at 48 weeks will be used to assess the direct effect of the intervention by
determining if there is a significant difference between the mean HAM-D and HbA1c scores in
the intervention and control arms. Within-subject analysis will be performed among patients
in the intervention arm by applying the Generalized Estimating Equations (GEE) method on
repeated measures data. To examine the role of social support and mental health stigma as
mediating factors in the relationship between depression and both treatment adherence and
levels of glycaemic control outcomes, three simple regression analyses each between i) the
predictor (social support and mental illness stigma) and outcome (HbA1c and HAM-D scores),
ii) predictor and mediator, and iii) mediator and outcome, will be conducted followed by a
multiple regression analysis.
