الفهرس 
INTRODUCTIONOnly 14 pages are availabe for public view
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Abstract
Diabetes mellitus is a major health problem affecting ≈ 424.9 million adults
worldwide. Care of DM aims to get euglycemia, prevent / delay its complications and
improve patient quality of life. CE has proven essential for the success of various public
health interventions. DCM is an educational healthcare approach focusing on patient
priorities and empowerment. Several DCMs have been developed and their effectiveness
have been evaluated everywhere.
The belief in CE effectiveness in the management of chronic diseases and availability
of trustable and respectable CPs having good integrated people centered (IPC) skills
everywhere attracted the attention towards the key role of CPs in promoting the DM care.
The present CBPR tested the effectiveness of CPBI of a DCM in a sample of 10 clusters
owing 10 CPs and 18+ years 100 health insurance-deprived T2DM patients with >7%
HbA1c in a 6-month prospective 2 X 2 RCT with crossover (one month) in Amria district,
Alexandria governorate. The clusters were randomly divided into 5-cluster UC/CPBI (5
CPs+50 patients) and 5-cluster CPBI/ UC (5 CPs+50 patients) groups (arms) or simply
termed groups I & II respectively. Development of the current CBDCM was inspired by the
DSMES standards, the ADA guidelines and Wagner 6-component CCM. It entailed master
leadership (team)/Tier 1, self-management strategy, supportive monitoring/ Tier 2,
communication net, community sourcing, and CP-led care/ Tier 3. It focused on patientcenteredness, HCP-patient partnership/concordance and patient empowerment. It tackled the
cognitive, clinical, social and medicinal factors that affected DM healthcare in a bid for
optimizing its control outcomes. The study passed into 3 phases; a 3-month first period (P1)
with 1st baseline (B1), a 1-month washout of the intervention effect & crossover, and a 3-
month second period (P2) with 2nd baseline (B2). CPs training on the DCM and optimal DM
care was done just prior to the start of P1 and P2. At B1, all patients filled a pre-deigned
interview questionnaire including all socio -demographic, habitual, clinical, medicinal &
economic data; knowledge of DM and the challenges to its optimal control. Again, Morisky
medication adherence, 18-Q short term patient satisfaction, 6-item patient self-efficacy scale,
and WHOQOL-BREF checklists were filled at baseline, and the end of P1 and P2. Only 94
and 86 of the recruited patients completed P1 and P2 respectively. The BP, WC, FBG,
HbA1c, TC, TGs, LDL-C, HDL-C, PCR and GFR were measured at B1 and B2. Then, the
BP, WC and FBG were monthly checked, while the others were measured at the end of P1
and P2 only. Using SPSS version 25, the collected data were statistically analyzed by means
of χ2, ANOVA, student t test, correlation coefficient and multivariate analysis.
The analyses revealed:
1- Baseline data:
1.1 Groups I and II didn’t vary significantly in the preponderant illiteracy (90% vs 92%),
marital status-marriage (82% vs 84%), nonsmoking (68%vs 70%), working status
(52% vs 48%) female sex (60% vs 54%), age group of 40-60 years (62% vs 78%),
physical inactivity (68% vs 76%), crowding index (64% vs 66%), and no regular check
up every 3-6 months (82% vs 90%).
1.2 At B1, most of groups I and II were on OHGDs (78% vs 86%) followed by insulin
(12% vs 12%) and OHGDs + insulin (2% vs 10 without significant variations inbetween them.
1.3 No significant differences between groups II and I were seen in the frequency of
asymptomatic T2DM (16.5% vs 10%), polyphagia & weight loss (14.6% vs 12.3% ),
polydipsia & polyuria (9.7% vs 12.3%), vaginal itching (11.7% vs 10%), erectile
dysfunction (5.2% vs 9.2%), headache (2.9% vs 9.2%), comorbidity of hypertension
(12% vs 20%), family history of T2DM & hypertension (15-16% vs 16%), and the
metabolic syndrome (68% vs 72%).
1.4 Groups II and I differed significantly the age at onset of T2DM (36.0+9.3 vs 43.5+10.3
years), duration of T2DM (15.2+13.1 vs 7.0+6.2 years), BMI (31.2±5.0 vs 27.2±3.8
kg/m2
) and WC (110.4 ±15.7 vs 101.9±12.5 cm); Z= of 3.6, 4.4, -4.7 & -3.1
respectively (P<0.01). No significant differences in the HR, SBP and DBP could be
deduced in-between the two groups.
1.5 group I had significantly higher daily intake of trans-fatty acid (34%) than group II
(18%) and vice versa for the weekly the intake (16% vs 40%). X2 = 7.9, P < 0.05.
1.6 While TGs varied significantly between groups II and I (161.52 ± 44.96 vs 141.66 ±
24. 25 mg/dl), Z= -2.378; P <0.017, none of the HbA1c, TC, LDL, HDL, PCR, and
GFR did.
1.7 The frequency of highest and lowest true answers of the 11 questions about knowledge
of DM were more in group II than group I (Q5: 68% vs (58% Q5) & (Q2: 46% vs
(38%).
1.8 High, medium and low drug adherence were respectively equal in groups I & II (16%),
higher in group II than group I (46% vs 38%), and higher in group I than group II (46%
vs 38%). The differences in-between were statistically insignificant.
1.9 Low education level, no regular checkup, physical inactivity, no dietary regimen,
misperception of DM symptoms, inability to purchase expensive prescribed drugs,
misguidance by alternative medicine and advertisements and non-adherence to
prescribed medicine were the barriers against optimal DM control dictated by groups
I and II with no significant differences in-between them.
2- Outputs of interventions:
2.1 Except for convenience and accessibility, other satisfaction 6 parameters (general
satisfaction, technical quality, independent manner, communication, financial aspects,
and time spent with doctors) were significantly higher with the CPBI (2.5, 2.7, 2.5,
2.5, 2.5, & 2.5) than he UC (2.0, 2.3, 1.5, 2.0, 1.5, & 1.5), P <0.01.
2.2 Significant increase in the range of true knowledge of DM on exposure to the CPBI
than UC (87.6 - 94.4%) versus (41.1 - 63.9%), P < 0.05.
2.3 Unlike the UC, the CPBI markedly raised Morisky scores of high and medium
adherence to the prescribed drugs in groups I (23.3% & 74.4% vs 18.6% & 46.5%), II
(28.3% & 54.3% vs, 17.4% & 34.8%) and both I & II (25.8% & 64% vs 18% &
40.4%), (P <0.01)2.4 In contrast to UC, exposure to CPBI significantly raised the score of self-management
in groups I (6.2±0.7 vs 6.7±1.3), II (4.8±0.99 vs 6.3±1.3, and) and both I & II (4.7±1.1
vs6.2±1), P <0.01.
3- Outcomes of interventions:
3.1 In comparison to UC, exposure to CPBI significantly increased the physical activity
(40 vs 21); whole grain weekly intake (53 vs 37) and vegetables/ fruits weekly (49 vs
39) and daily (36 vs 22) intake, (P < 0.001), and lowered the weekly intake of each of
the processed meat (13 vs 23), trans-fatty acids (23 vs 28) and sugary drinks (10 vs
40), (P < 0.001).
3.2 Significant CPBI-evoked increased frequency of asymptomatic DM (CPBI 31.9% vs
UC 12.9%), and reduced frequency of the classical DM symptoms [polydipsia (8,3%
vs 11.4%), polyphagia (10.4% vs 13.2%), polyuria (4.2% vs 6.4%), & weight loss
(4.2% vs 11.9%)], vaginal itching (6.9% vs 11%), and loose teeth (1.4% vs 4.1%)
along with increased complaints of erectile dysfunction (7.6% vs 6.8%), blurred vision
(3.5% vs 2.7%) and numbness (4.9% vs 4.1%); X2 = 31.33, P < 0.05. Significant CPBIinduced DROP in the frequency of metabolic syndrome was seen in groups I (CPBI
16.5% vs UC 51.2%), II (19.6% CPBI vs 50% UC), both I & II (18% vs 50.6%). X2
values were 16.5, 13, and 14.1 respectively; P < 0.01.
3.3 Exposing groups I (P1) and II (P2) to UC evoked little to mild rise in SBP [group I:
B1 127.34± 18.39, M1: 127.98±18.31, M2: 127.39±18.22 & M3: 126.74±18.80 and
group II: B2 121.44±10. 87, M1:121.77±10.99, M2:122.28±11.05&
M3:122.98+9.10.432], DBP [groups I: B1 81.30±11. 40, M1: 81.57±11.37, M2:
82.46±11.30, M3: 82.73±11.27 and group II: B2: 79.74±8.17, M1: 80.35±8.21; M2:
81.28±8.13; & M3: 82.54±9.05] and WC [group I: B1 101.37±12.63, M1: 101.
85±12.41, M2: 102.48±12.58, M3: 104.61±12.26, and group II: B2:105.72±14.83,
M1: 106.21± 18.89; M2:106.57±14.83; M3:106.91±14.85]. Simultaneous exposure of
groups II (P1) and II (P2) to CPBI induced prominent DROP in the SBP [group II: B1
128.81±16.49, M1: 124. 72±16.8, M2 :124.12±16.76 & M3:121.33±10.81 and group
I: B2 127.5±18.78, M1: 124.39±18. 81; M2: 123.30±18.82; & M3: 121.26±13.92],
DBP [group II: B1 83.07±11.28, M1: 81.70± 11.35, M2: 80.68±11.67, & M3:
79.49±12.24 and group I: B2 83.37±11.42, M1: 81.70±11.35, M2: 80.68± 11.67; &
M3: 79.49±12.24] and WC [group II: B1: 110.42±16.91, M1: 108.35±16.43, M2:
105.61±16.67, & M3: 105.10±14.83 and group I: B2: 104.86±13.31, M1:
103.95±12.05, M2: 103.47±12.03; & M3: 97.84±11.94] The overall differences in the
SBP, DBP and WC between the two groups were significant with F values of 6.1, 4.41,
and 8.13 respectively (p <0.01).
3.4 Compared to the slight decrease with UC, FBG dropped steadily with CPBI in groups
I (P2) [B2: 209.6 ± 63.5, M1: 146.8 ± 50.4; M2: 133.2 ± 44.0; & M3: 129.4 ± 46.7]
and II (P1) [B1: 260.1± 105.7, M1: 181.5 ± 69.8, M2: 153.5 ± 51.8, & M3: 143.1 ±
53.4); F= 30.62, (P < 0. 001).
3.5 By end of P1, compared to the B1, HbA1c had solid increment and decrement in group
I [B1: 9.44± 2.4 vs P1: 10.73±1.8] and group II [B1: 9.76±2.3 vs P1: 7.34±1.1]
respectively and vice versa by end of P2 (group I: B2 10.75±1.7 vs P2 9.4±2.3 and
group 1I: B2 7.33±1.2 vs P2 9.82±1.7]. Similar findings were seen with TGs by the
end of P1 [group I: B1 139.4±23.3 vs P1 142.65± 22.6 and group II: B1 163.7±46.1 vs .1±27.8] and P2 [group I: B2 143±22.4 vs P2 135±20.3 and group II: B2
138.7±27.7 vs P2 143±31.2]; F= 15.89, (p <0.01). LDL of group I remained the same
by end of P1 (138±28.9) yet dropped by end of P2 ( B2: 138.2±28.7 vs P2: 130±13.0).
That of group II dropped at the end of P1 (B1: 144.9±28.1 vs P1 122.4±16.7) and rose
again by end of P2 (B2: 122.8±15.9 vs P2 142.5±7.0); F= 12.23, (p <0.01). The TC of
group I decreased slightly by end of P1 (B1: 205.9±63.9 vs P1 203.2±64.2) and
prominently by end of P2 (B2: 203.1±63.3 vs P2 173.5±40). In group II, it declined by
the end of P1 (B1: 212.4± 43.9 vs P1: 182.6±46.8) and rose again by the end of P2
(B2: 183.0±45.9 vs P2: 205.3±34.9); F= 21.29, (P <0.01).
3.6 The mean scores of quality of life (QOL) social, psychological, environmental and
physical parameters were much higher with CPBI than UC in group I (social 74.2±16.9
vs 57.9±10.6, psychological 70.8±9.0. vs 54.1±12.2, environmental 71.1±43.0 vs
53.7±10.4 & physical 60.7±6.8 vs 58.0±7.4), group II (social 74.5±14.6 vs 62.0±12.6,
psychological 67.0±11.8vs 53.6±10.5, environmental 55.2±9.3 vs 71.7±10.9 &
physical 61.3±8.2vs 55.9±7.7) and groups I & II (social 74.3±15.7 vs 60.0 ± 1.8,
psychological 74.5±11.1 vs 53.8 ±13.6, environmental 71.4±11.6 vs 54.4± 9.8 &
physical 75.4±8.4 vs 61.0±7.5), (P < 0.01).
3.7 Against UC, CPBI markedly reduced the monthly cost of medicines/ patient
(28.8±18.2 vs 49.3± 26.6), t=6.7; frequency of dosage (1.6±0.6 vs 2.0±0.7), t =4.1; and
insulin doses (52.5±15 vs 70.34 ±10.8), t= 5.28, (P< 0.05). The ICER of reducing the
mean HbA1c by 1.77% and 1% equals 1668 LE / patient/ 3month, and 942 LE / patient/
3month respectively
3.8 Positive correlations between HbA1c, TC, TGs, LDL, and HDL with their baseline
levels were found. HbA1c directly correlated with T2DM duration (r = 0.316) yet
inversely correlated with age at onset of T2DM (r = -0.369) and weight (r =-0.228).
Positive correlation between LDL and each of body weight (r =0.29) and WC(r
=0.281); inverse correlation between HDL and patient age (r-0.22); and positive
correlation between TGs and each of body weight (r =0.222), baseline LDL(r =0.66),
and baseline cholesterol (r =0.221) were found as well, (p <0.05).
3.9 Multivariate analysis entailed all univariate analyses-derived independent significant
variables and scores. Patient satisfaction, knowledge, adherence to medicines and selfmanagement were respectively affected by CPBI (β= -0.84, P=0.001); satisfaction
(β=0.77, P=0.001); knowledge (β =0.3, P=0.001); and adherence MS (β= 1.46,
P=0.001). HbA1C was strongly influenced by self-management (β= 0.16, P=0.01),
baseline HbA1C (β= 0.71, P=0.01), eating vegetables (β= -0.21, P=0.01), eating transfats (β= -0.44, p= 0.01), and T2DM duration (β= -0.13, P= 0.01). TC in turn was
affected by higher education (β= -0.247, P=0.022) and intake of trans-fats (β=0.343,
P=0.01) & processed meat (β=0.268, P=0.015). There were affection of TGs by WC
(β=0.303, P=0.01), baseline HbA1C (β=0.327, P=0.01), patient knowledge (β= -0.27,
P=0.02), and age (β=0.231, P= 0.03); patient QOL by self-management (β=77.22,
P=0.01); and cost-effective T2DM control by CPBI intervention (β= -85.42, P =0.01).