Wakefield 2011.
| Methods | Randomized controlled trial | |
| Participants | The study location was Iowa City VA Medical Center (ICVAMC), Iowa, USA 93 participants were randomized to the high intervention group, 102 participants were randomized to the low intervention group and 107 participants were randomized to the control group The inclusion criteria were coexisting diabetes mellitus and hypertension, a land‐line telephone in the home, receipt of primary care from the VA in the previous 12 months, and anticipation of receiving primary care for the duration of study enrollment The exclusion criteria were legally blind, resided in a long‐term care facility, or who had diagnoses indicating dementia or psychosis |
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| Interventions | Intervention: HIGH‐INTENSITY GROUP
In the high‐intensity group, subjects were instructed to measure BP daily and blood glucose (BG) as directed by their physician, that is, frequency of home BG monitoring was not changed. The study team developed a branching disease management algorithm based on DM and HTN guidelines from the VA, American Diabetes Association, and the American Heart Association. The algorithm was programmed into the device and focused on diet, exercise, smoking cessation, foot care, advice for sick days, medications, weight management, preventive care, and behavior modification and lifestyle adjustments. A schedule was established for each prompt set so that subjects received both standard prompts each day and a rotation of questions and educational content. Follow‐up was for a period of 12 months Intervention: LOW‐INTENSITY GROUP In the low‐intensity group, subjects were instructed to measure BP daily and BG as directed by their physician. Subjects in this group responded to a small subset of questions from the larger set of questions used with the high‐intensity group. Every day, subjects in this group were asked, "Have you taken all your medications as prescribed?" In addition, subjects were prompted with one additional question each day focused on diet, exercise, foot care, or medication side effects. These questions did not use the branching algorithm used for the high‐intensity group, rather they used yes/no or multiple choice responses Control: USUAL CARE Usual care subjects scheduled follow‐up appointments with the primary care clinic in the usual manner. Subjects had access to their nurse care manager employed by the medical center |
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| Outcomes | The measures of adherence were the Self Reported Medication Taking scale. It includes 4 items addressing medication‐taking behavior in patients with hypertension. The scale has been shown to have acceptable reliability, with individuals scoring high on the scale are significantly more likely to have their blood pressure under control compared with individuals who scored low (r = 0.58; P value < 0.01) at 42‐month follow‐up. For diabetes mellitus, a validated regimen adherence scale was used, which addresses medication, diet, exercise, and BG testing. Data were collected at baseline, and 6 and 12 months The patient outcomes were hemoglobin A1c level and systolic blood pressure. Blood was drawn and analyzed for A1c by the ICVAMC Laboratory. BP was measured by study staff using an automated BP machine according to recommended standards. Data were collected at baseline, 6 months, and 12 months. Data were collected by scheduling clinic visits for all subjects |
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| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomization method is not stated. "We targeted patients who had an upcoming Primary Care Clinic appointment, with a goal of sending letters to a maximum of 10 patients per day. Although it occurred infrequently, if there were more than 10 patients from our pool with a clinic appointment on a given day, we randomly selected 10 potential subjects, using a random number generator to select patients." "This study was a single‐center, randomized, controlled clinical trial design comparing three treatments, two remote monitoring intensity levels and usual care, with respect to improvement in outcomes in patients with comorbid DM and HTN. Primary outcome measures were A1c and SBP." (pg 254). Insufficient information about participant randomization to the different study groups: "Randomization occurred after consent and collection of baseline data. Group assignments were made by the study nurses using sequentially numbered, sealed, opaque envelopes prepared in advance by the project director.'' (pg 255) |
| Allocation concealment (selection bias) | Low risk | "Randomization occurred after consent and collection of baseline data. Group assignments were made by the study nurses using sequentially numbered, sealed, opaque envelopes prepared in advance by the project director." (pg 255) |
| Selective reporting (reporting bias) | Unclear risk | None detected; protocol unavailable |
| Other bias | Unclear risk | "Limitations: On average, subjects who enrolled in this study had relatively good baseline control for A1c and SBP; thus, this sample may represent patients who were more highly motivated to manage their chronic illness. Because these data were collected in a Midwestern VA Medical Center, minorities and women were underrepresented. Patients without telephones could not participate; this may have excluded the most economically disadvantaged patients for whom the intervention would be the most effective. The study was not designed to measure outcomes beyond the 12‐month follow‐up period, so longer‐term effects were not measured." (pg 259). "Subjects had relatively good baseline control for A1c and SBP; minorities and women were underrepresented." (pg 254) |
| Blinding of outcome assessment (detection bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORTED MEDICATION TAKING SCALE ‐ 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) BLOOD SAMPLE ‐ This is an objective measure of outcome |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) BLOOD PRESSURE (BP) ‐ This is an objective measure of outcome. Used an automatic BP machine |
| Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) SELF REPORTED MEDICATION TAKING SCALE ‐ This is a subjective measure; there is no information on blinding |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) BLOOD SAMPLE ‐ This is an objective measure of outcome |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) BLOOD PRESSURE (BP) ‐ This is an objective measure of outcome. Used an automatic BP machine |
| Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORTED MEDICATION TAKING SCALE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) BLOOD SAMPLE ‐ This is an objective measure of outcome |
| Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) BLOOD PRESSURE (BP) ‐ This is an objective measure of outcome. Used an automatic BP machine |
| Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORTED MEDICATION TAKING SCALE ‐ imbalance in attrition rates |
| Incomplete outcome data (attrition bias) Patient outcome | Unclear risk | (PRIMARY) BLOOD SAMPLE ‐ imbalance in attrition rates |
| Incomplete outcome data (attrition bias) Patient outcome | Unclear risk | (PRIMARY) BLOOD PRESSURE (BP) ‐ imbalance in attrition rates |