Zolfaghari 2012.
| Methods | Randomized controlled trial | |
| Participants | The study location was Tehran, Iran 38 short message services (SMS) participants were randomized to the intervention group and 39 telephone follow‐up participants were randomized to the control group The inclusion criteria were to have telephone access in their homes and their own personal mobile phones, or have access to one belonging to a relative, age 18 or above. They could only used oral antidiabetic medications. The had to be able to read and write, had sufficient power vision, had no problem in hearing and vocalization and did not have a history of psychiatric diseases The exclusion criteria were clinical history of an important illness such as renal insufficiency with a creatinine level > 1.5 mg/dl, hepatic insufficiency, mentally ill or had < 7% of HbA1c |
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| Interventions | Intervention: SHORT MESSAGE SYSTEM (SMS) GROUP
Participants in both groups received 3 days of diabetes self care education sessions. Before the intervention, the SMS group received 10 minutes of instruction on how to use their cell phones and check their ability to read the SMS. The intervention was provided for 3 months. Patients in the SMS group received about 6 messages every week (excluding holidays) that consisted information about taking a diet, exercising, diabetic medication taking, frequent self monitoring of blood glucose levels and stress management. Overall, 72 messages were sent to patients during intervention, and the length of each message was not more than 160 features. Participants in the SMS group could receive messages at any place where access was possible by cellular phone. The researcher sent optimal recommendations back to each patient, 6 times by SMSs of a cellular phone weekly. Control: TELEPHONE INTERVENTION GROUP The intervention for the telephone group was provided via telephone for 3 months. The intervention was provided by counseling scheduled appointments – whenever the time was convenient to the subject. The content of intervention consisted of counseling on the nature of the disease, risk factors, importance of maintaining blood glucose levels within a near‐normal range, continuous education and reinforcement of diet, exercise, medications taking, hypoglycemia management, illness management, how to record daily blood glucose and frequent self monitoring of blood glucose levels. The researcher contacted the telephone group at least twice a week for the first month and then weekly for the second and third month. The total frequency of telephone counseling averaged 16 times per subject. The average length of these contacts was 20 minutes per call. The researcher asked questions about the diet: 'Did you eat salad and vegetable before every meal?', 'How many days did you follow your recommended diet over the past days?' 'Did you eat your meals at regular times?' and…some recommendations about exercising such as: 'How many times did you do physical exercising or walking during the last days?' 'When is the best time to exercise'? 'Did you feel better after exercising?' 'Do you know that exercising is as important as diabetic medication?' and…medication related questions were: 'Did you take your recommended diabetic medication?' 'When did you consume your prescribed tablet? 'Do you know how your consuming medications, act in your body?'…and so on |
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| Outcomes | The measure of adherence was self reported adherence, which was measured by self care diabetes questionnaire during 3 stages of the study: at baseline, 3, and 6 months. The questionnaire consisted of 3 items: demographic characteristics, disease characteristics and questions related to adherence therapeutic regimen namely diabetic diet, physical exercise, and diabetic medication taking. The score of '4' was given for an achieved goal and '0' for a non‐achieved goal The patient outcome was HbA1c, measured at baseline and at 3 months by a high‐performance liquid chromatography technique |
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| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | They were randomized by random permuted block design using a random number table and assigned to one of 2 groups: SMS group (n = 39) or telephone group (n = 41) |
| Allocation concealment (selection bias) | Unclear risk | No information about how allocation was handled. "They were randomised by random permuted block design using a random number table and assigned to one of two groups: SMS group (n = 39) or telephone group (n = 41)." (pg 1924) |
| Selective reporting (reporting bias) | Unclear risk | No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol |
| Other bias | Unclear risk | There is insufficient rationale or evidence that an identified problem in the limitations will introduce bias |
| Blinding of outcome assessment (detection bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) HBA1C LEVEL ‐ This is an objective measure of outcome |
| Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) HBA1C LEVEL ‐ This is an objective measure of outcome |
| Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No information on blinding. Insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) HBA1C LEVEL ‐ This is an objective measure of outcome |
| Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Fairly similar attrition, but there was a small sample size so it is unclear |
| Incomplete outcome data (attrition bias) Patient outcome | Unclear risk | (PRIMARY) HBA1C LEVEL ‐ Fairly similar attrition, but there was a small sample size so it is unclear |
ACE: angiotensin‐converting enzyme ACR: American College of Rheumatology ACTG: AIDS Clinical Trials Group AHA: American Heart Association AMI: acute myocardial infarction
AP: anti‐psychotic ARB: angiotensin receptor blocker ART: antiretroviral therapy ARV: antiretroviral AT: adherence therapy
AVRF: audiovisual reminder function BDI: Beck Depression Inventory
BG: blood glucose BMI: body mass index BP: blood pressure BPRS: Brief Psychiatric Rating Scale
CDSMP: chronic disease self‐management program CES‐D: Center for Epidemiologic Studies Depression Scale CHD: coronary heart disease
CHF: chronic heart failure CI: confidence interval COPD: chronic obstructive pulmonary disease CRP: C‐reactive protein CV: cardiovascular DBP: diastolic blood pressure
DKA: diabetic ketoacidosis DMAS: Disease Management Assistance System DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders ‐ IV ECG: electrocardiogram ED: emergency department ER: emergency room EULAR: European League Against Rheumatism FEV1: forced expiratory volume in one second FVC: forced vital capacity
FP: fluticasone propionate
FRS: Framingham risk score GAF: Global Assessment of Function GP: general practitioner HAART: highly active antiretroviral therapy HCV: hepatitis C virus
HCTZ: hydrochlorothiazide HDL‐C: high‐density lipoprotein cholesterol HF: heart failure
HPP: health promotion program ICD‐9, ICD‐10: International Statistical Classification of Diseases and Related Health Problems (9th revision, 10th revision) ICS: inhaled corticosteroids INR: international normalized ratio IOP: intraocular pressure IPQ‐R: Revised Illness Perception Questionnaire ITT: intention‐to‐treat IV: intravenous
JNC: Joint National Committee LABA: long‐acting beta‐agonist LDL‐C: low‐density lipoprotein cholesterol LV: left ventricular
MARS: Medication Adherence Rating Scale MDI: metered‐dose inhaler
MGL: Morisky‐Green‐Levine Test MEMS: medication event monitoring system MI: myocardial infarction MMSE: Mini Mental State Examination
NNRTI: nonnucleoside reverse transcriptase inhibitor NYHA: New York Heart Association OCP: oral contraceptive pill
OP: on protocol OR: odds ratio PANSS: Positive and Negative Syndrome Scale
PCP: primary care physician PEF: peak expiratory flow
Peg‐INF: peginterferon (Peg‐IFN) PEP: post‐exposure prophylaxis PI: primary investigator PV: plasma viscosity QLS: quality of life scale QoL: quality of life
RBV: ribavirin RCT: randomized controlled trial
RN: registered nurse
RRB: risk reduction behaviours SABA: short‐acting beta‐agonist SBP: systolic blood pressure
SCID: Structured Clinical Interview for DSM Disroders SGRQ: St George's Respiratory Questionnaire
STOPS: Supevised Treatment in Out‐patients for Schizophrenia T & A: tonsillectomy and adenoidectomy TAU: treatment as usual URTI: upper respiratory tract infection
VA: Veterans Affairs
VAMCs: Veterans Affairs Medical Centers WHO: World Health Organization